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A Progressive and Exciting Workplace

At Acumed, the people who work here are our most valuable asset. By providing a dynamic environment that supports individual growth and responsibility, we’ve been able to hire, and retain some of the brightest minds in healthcare. We believe strongly that each of our employees makes an impact on the lives of the patients who receive our products. Which is why we encourage everyone within the company to push the limits of their expertise, whether it’s in engineering, production, inspection, marketing, or regulatory and compliance. Personal health and happiness are highly valued at Acumed, and we devote a significant amount of resources to ensure it. We provide benefits that enhance medical care, help plan for the future and promote general well being.

Acumed is currently hiring for a variety of positions. To apply for an open position, please visit our careers portal.

Benefits Include . . .

  • Generous PTO
  • Medical, dental, and life insurance
  • Short and long-term disability insurance
  • 401(k)
  • Nine paid holidays
  • Retirement plan
  • Flexible spending accounts
  • Educational assistance
  • TriMet bus pass subsidy
  • Costco membership subsidy
  • Gym membership subsidy
  • An employee referral program
  • Bike room and showers

Current Open Positions

Position Location Department Posted Onsort descending
Product Manager, Acute Innovations Hillsboro, OR, USA Acute Product Management Jul. 08, 2015
ACUTE Innovations, a subsidiary of Acumed, is looking for an energetic Product Manager to help our business continue to grow! ACUTE offers an innovative product portfolio, a robust benefits package, and a strong employee culture.

The Product Manager plans, organizes, and controls an assigned ACUTE Innovations Product Segment/family from conceptual stages through product life cycles to optimize profit and meet marketing, financial and corporate growth objectives.

Duties/Responsibilities
• Assists in developing strategies to adjust and promote various product lines, to improve sales and profit.
• Develops and manages action plan(s) for new product introduction.
• Oversees the formulation of marketing strategies and tactical execution including pricing, selection or market segments for special emphasis, promotional and advertising support of sales, and specifying the necessary product characteristics.
• Works closely with internal and external resources to determine business unit needs for growth.
• Directs medical education courses including setting the faculty, initiating the topics to be covered, and working with surgeons in presentations to help promote ACUTE Innovations product.
• Develops relationships with key surgeon consultants to drive product sales.
• Participates in conventions and professional exhibitions to maintain company image and remain aware of product requirements and new market opportunities.
• Prepares long range, annual, quarterly, and monthly forecasts for each product line. Analyzes forecasts variances and recommends corrective actions to minimize future back orders or potential obsolescence. Reviews forecast for product requirements and originates plans and objectives to continually be competitive with or ahead of market needs.
• Develops and maintains product line technical expertise and contacts with key surgeons and customers of product responsibility by observing surgery, attending medical/scientific meetings, presentations, and seminars while gathering competitive information.
• Determine list pricing for all assigned products via thorough competitive analysis, market trends, etc.
• Conducts market research activities to analyze and identify market needs and issues. Evaluates existing ACUTE Innovations product lines in light of those changes and develops line simplification strategies when appropriate.
• Trains and assists ACUTE Innovations field representatives on products and competition.

Qualifications
• BA/BS in marketing, communications or related field.
• At least 5+ years of experience in a sales or classical marketing function, preferably with direct product management experience
• Background in orthopedic products or medical devices highly preferred
• Strong interpersonal and relationship management skills
 

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Regulatory Affairs Specialist III Hillsboro, OR, USA Regulatory Sep. 08, 2015

The Regulatory Specialist III will function as the regulatory representative in the product development process to develop and execute product strategies. The Specialist will provide training and support for internal stakeholders, external customers, and the relevant competent authorities. In addition, the Specialist will perform local country surveillance for assigned regulatory activities. Also, the Regulatory Specialist will ensure all records and systems supporting regulation are adequately maintained and compliant to current regulations.


Duties/Responsibilities
• Must have a self-driven ability to investigate and understand regulations. Senior-level employee that works well independently and with a team, depending on the situation requirements.
• Initiate and maintain required establishment listings for FDA, EU MDD and CMDCAS including renewal or changes
• Initiate and maintain accurate international product registration, including renewal or changes, and certificates for foreign governments
• Manage correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, ISO, Acumed's EU Authorized Representative
• Prepare, organize, coordinate content/data and ensure regulatory compliance for submission to the FDA or regulatory agencies (e.g. 510(k), PMA, MDD Technical Files/Design Dossiers, global registration applications, etc.)
• Ensure all processes for the essential functions are documented in procedures
• Review and disposition ECRs/ECOs for potential impact to new and existing registrations.
• Review of all Product labeling to assure compliance with registrations.
• Assist in determination of appropriate product testing to support registration activities.
• Determine the best strategy to register new products in specific global markets


Qualifications
•  Bachelor's degree required in Regulatory Affairs, Biology, Chemistry, Engineering, or related field

• 3-5+ years of related experience required
• Evidence of applied knowledge of applicable FDA, CMDCAS, ISO, MDD, region-specific requirements and consensus standards
• Ability to work with FDA, Notified Body, EU Authorized Representative and other global regulatory agencies
• Able to manage multiple projects simultaneously
• Proven track record of strong team work, creatively strategic thinking
• Ability to work well with others, support regulatory activities and mentor/train others
• Excellent written and verbal communication skills

 

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Senior Product Manager Hillsboro, OR, USA Product Management Oct. 01, 2015

Acumed is looking for a Senior Product Manager to Develop and manage the long-term strategic vision of an assigned Acumed product indication portfolio through the product life cycle. The Senior Product Manager will lead the development of the portfolio strategy by capturing the voice of customer, and has advanced knowledge of the global orthopedic market environment. This position works with the Product Management team and other departments within the company to drive strategic upstream and downstream activities, and gathers data to facilitate business decisions regarding product development and portfolio strategy that are communicated across key Acumed stakeholders.

This is a great opportunity for a high-energy product manager seeking an growth opportunity in the fracture management space!

Duties/Responsibilities
• Oversee the formulation of short-, mid-, and long-term product portfolio strategies and tactical execution including pricing & reimbursement strategy, global registration & distribution strategy, and clinical data strategy.
• Ensure product line strategy and products released to market meet the voice of the customer.
• Drive and creates value proposition and works with Marketing to develop messaging for each product and customer segment in assigned portfolio.
• Understand and communicate market trends, sales trends, market share, and unit sales trends for each product line in assigned portfolio.
• Collaborate with internal and external resources to determine future product development projects in order to maintain growth in alignment with overall corporate objectives.
• Prepare long range, annual, quarterly, and monthly forecasts for each product line. Analyze forecast variances and recommend corrective actions.
• Develop and maintain product line technical expertise and contacts with customers by observing surgery, attending medical/scientific meetings, presentations, and seminars.
• Develop relationships with surgeon consultants to drive product development and educational programs.
• Utilize primary and secondary market research reports to analyze and identify market needs and issues. Evaluate existing Acumed product lines in light of those changes and develop new strategies when appropriate.
• Conduct domestic and international product training programs for internal and external customers. Train Acumed field representatives on Acumed products and the competition at a product expert level.
• Propose Product Management Selling, General, & Administrative budget for new product development projects.
• Represent Acumed at tradeshows and educational courses to increase awareness of new product requirements and market opportunities.
• Manage feedback from field regarding Acumed product and enter data into product feedback database and the Acumed complaint system.
• Responsible for taking and answering technical calls regarding Acumed products, both during and outside of regular business hours.


Qualifications
• BA/BS in marketing, communications or related field required
• 5+ years of experience in a sales or classical marketing function, preferably with direct product management experience
• Background in fracture management highly preferred
• MBA highly preferred
• Ability to work collaboratively and independently in a cross-functional and team oriented environment
• Strong oral and written English skills (both in groups and one-on-one interaction)
• Strong analytical skills and ability to deliver results with multiple and complex project
• Previous experience with coaching required
• Strong working knowledge of MS Office Suite (Word, Excel, Outlook)

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

CNC Machinist II (swing shift) Hillsboro, OR, USA Production Nov. 18, 2015

The Machinist produces medical devices using manual and CNC equipment while ensuring product is loaded and unloaded correctly per standard operating procedures. This is a great Machinist opportunity that offers a robust benefits package, a 401k plan, and a generous Paid Time Off program!

Shift: Swing Shift M-Th 3:00pm - 1:30am

Work Location: Cornelius Pass Plate Cell

Duties/Responsibilities
• Under close supervision, efficiently operates production machine tools to maintain Quality, Cost and Delivery.
• Starts and observes machine operation to detect malfunctions or out-of-tolerance machining.
• Visually inspects surfaces for flaws and smoothness.
• Empties chip bins.
• Sweeps and cleans work area and equipment.
• Use established practices to ensure Quality during operation including documentation and techniques.
• Monitor machine performance.
• Perform preventative maintenance as required.

Qualifications
• Generally requires 2-4 years related experience.
• General set-up competency on Cell specific Machine Tools.
• Demonstrated troubleshooting skills and basic programming understanding.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Compliance Audit Specialist Hillsboro, OR, USA Compliance Dec. 03, 2015

The Compliance Audit Specialist (CAS) develops and implements Acumed's annual compliance audit plan including scheduling and execution. The CAS will conduct approved internal audits and be responsible for the development of the Compliance Annual Risk Assessment. The CAS will identify risks related to the sales and marketing of medical devices, collaborate with management to identify proper risk management strategies along with monitoring industry developments and market conditions. In addition, the CAS will manage outsourced audits to completion. The Compliance Audit Specialist will provide guidance and advice on internal controls including responding to questions on risk management techniques.

Duties/Responsibilities
• In collaboration with the Director of Compliance, and with Executive approval, creates, distributes, administers and maintains the annual internal audit plan.
• Establishes and monitors key risk indicators and recommends corrective action plans to mitigate identified risks.
• Analyzes business and financial transactions, internal reports, and financial information of Independent Sales Contractors, distributors, subsidiaries and business partners for potential fraud risks.
• Collaborates with management to identify proper risk management strategies and implements approved recommendations.
• Regularly disseminates reports of significant risks and mitigation recommendations.
• Makes recommendations for policies, procedures and control assessments in response to identified risks.
• Evaluates the effectiveness of the Company's internal controls in addressing sales compliance risks.
• Once approved, owns and executes the completion of the Compliance Annual Risk Assessment.
• Manages within approved budget any resources used to complete segments of the annual audit plan identified for completion externally.
• Assists in the training of business partners in areas of risk for fraud, bribery and corruption.
• Monitors industry developments and market conditions related to sales compliance including Advamed Code of Conduct provisions and updates.

Qualifications
• Bachelor's degree in finance, economics, business management, statistics or related field required.
• MBA, MPA, CPA, JD or other related professional degree is preferred.
• Certified Fraud Examiner (CFE), Certified Risk Analyst (CRA), Certification in Risk Management Assurance (CRMA), Financial Risk Manager (FRM), Professional Risk Manager (PRM) and/or Certified in Risk and Information Systems Control (CRISC) highly preferred.
• 3-5 years of experience in financial auditing or forensic accounting required; risk assessment experience preferred.
• Fluency in a foreign language such as Mandarin, Portuguese or Spanish is strongly preferred.
• Well-developed analytical, interpersonal, and communication (both written and verbal) skills with successful experience communicating effectively with all levels of organization.
• Demonstrated personal and professional integrity and discretion with respect to maintaining confidentiality of company and personnel related information.
• Exceptional organizational skills with extensive knowledge of MS Office (i.e. Excel, Word, Outlook).
• Self-motivated and able to work with little supervision.
• Strong analytical skill sets with the ability to conduct audits with close attention to detail and prepare reports with thorough analysis demonstrating results and recommendations.
• Proven success in executing improvement plans and activities that achieve expected results.
• Excellent presentation skills.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Field Education & Training Manager Hillsboro, OR, USA Medical Education Dec. 04, 2015

The Field Education & Training Manager is an international position that works in his/her territory to run or support local medical education events and distributor product training. The Field Education & Training Manager defines his/her territory's annual strategy together with his/her dotted line manager and works with his/her direct line manager to ensure education and training is executed in a consistent, high-quality standard.

General Duties/Responsibilities
• Define territory's annual medical education and product training strategy, aligning the strategy with the needs of the territory and the strategy of the company.
• Work with direct and dotted line managers to define performance metrics for which the FE&TM is responsible for measuring and report on monthly.
• Work at tradeshows, medical education and product training events in the field or at Acumed headquarters.
• Communicate surgeon and distributor feedback to the appropriate people at Acumed.
• Continuously build knowledge of the clinical practice of orthopedic trauma and Arthroplasty, Acumed and competitive products, support product knowledge training based on educational methodologies, published research and the overall managed care environment.
• Occasionally help with account conversions, customer service, surgical coverage, etc., but only as necessary and agreed upon by direct line manager.
• Maintain full compliance with Acumed's Code of Conduct and related FDA and AdvaMed regulations.

Qualifications
• BA/BS in a related field or equivalent experience required
• 3+ years medical sales experience (with 2+ years orthopedic / trauma sales experience) or 3+ years clinical orthopedic trauma experience required
• Ability to think strategically and to contribute in a team environment
• Knowledge of healthcare industry and trends
• Strong project management and product knowledge/integration skills, , market and industry knowledge, strong business acumen and planning skills
• Ability to master product knowledge and protocols
• Exceptional communication and teamwork skills, including relationships management skills
• Ability to demonstrate proper surgical use of our product to physicians
• Proficiency in computer word-processing, spreadsheets, and database applications. (MS Office).
• Exceptional problem-solving skills
• Ability to provide a home working office

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Senior Project Manager Hillsboro, OR, USA Project Management Dec. 14, 2015

The Senior Project Manager (SPM) independently plans, manages, and executes multiple New-Product-Introduction (NPI) projects simultaneously. The SPM is assigned to lead teams responsible for achieving project objectives including implementation. The SPM leads projects that are large and complex in nature as established by their scope and budget. The SPM works with the Program Manager to ensure timelines and budgets are in line with portfolio goals and objectives. They work with the Product Development Team to ensure the quality of the product and the product meets pre-defined product specifications and design criteria.


Duties/Responsibilities
• Leads assigned Product Development Team to achieve defined objectives.
• Manages 3 – 7 large, complex, high-risk projects simultaneously ensuring they are completed in accordance with project objectives for Cost, Scope, On-Time Delivery, and Quality (see appendix).
• Ensures complete and properly defined project scope by facilitating input (customer preference trials, voice-of-customer, etc.) and output activities and final documentation (IOVV information gathering and documentation).
• Establishes and maintains project scope throughout the project lifecycle, including initial setting of scope, and scope change management.
• Drives and manages Risk Management Planning with the team throughout the lifecycle of the project.
• Liaises with functional managers to ensure resource availability and minimum required skill level satisfies the needs of the project and schedule.
• Drives and facilitates proper validation and verification process to ensure customer use requirements (validation) and design intent is met (verification).
• Ensures long term history (for FDA audit, identification of best known methods, and future design leverage) is retained by ensuring completion and integrity of design history file regimen for each project.
• Facilitates labs for customer preference, design review, and product validation.
• Facilitates internal design reviews and technical problem identification processes and resolution methods as required
• Collaborates with the Program Manager and product management team to support the development of strategic product roadmaps.
• Coordinates and prepares reports for the Executive Team regarding status of projects and the preparation of Acumed Product Lifecycle documentation.
• Manages stakeholder expectations (sets, maintains, and re-sets as necessary) by regularly presenting and communicating with the Executive Team and all stakeholders the project status throughout the project lifecycle.
• Assists Project Managers in the development and implementation of recovery plans when projects get off track (i.e. scope, budget, or schedule).
• Collaborates with Program Manager to identify and drive Project Management and APLC process improvements.

Qualifications
• Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering or related field and 8-10 years of experience; MS or MBA degree plus PMP certification preferred; or PMP certification and 10 - 15 years of experience managing medium and large complex new product development projects in highly technical environments (i.e. High Tech, Medical, other) is acceptable in lieu of a bachelor degree.
• Experience in a formal gated project environment.
• Knowledge of ISO and FDA regulations required.
• High proficiency and demonstrated success with MS Project (or equivalent project management software such as Primavera) required.
• Other tools experience enabling methods such as Work Breakdown Structures, mind mapping, design reviews, root cause analyses and other problem resolution methods such as Ishikawa or 5Y are preferred.
• SAP Proficiency or significant experience with other main frame ERP systems is preferred.
• General knowledge of marketing, including market research, sizing, pricing, marketing communications and product launch.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Product Designer III Hillsboro, OR, USA Product Development Engineering Dec. 14, 2015

The Product Designer is responsible for designing new products and maintaining existing products, from concept through obsolescence. This includes research, idea creation and realization, product specification generation, and maintenance of product designs. The Product Designer must communicate with team members, managers, customers, and vendors in an effective manner.

Duties/Responsibilities
• Research product designs, concepts, indications, intended use and competitive landscape for new and existing product lines independently.
• Develop and create design concepts, product designs, specifications, working models/prints, and related documents required by Acumed to produce products independently.
• Maintain existing product designs through NCRs, alerts, complaints and other associated documents.
• Expected to provide technical design/drafting mentoring and coaching to other product development employees.
• Function as a Product Development representative on cross-functional Product Development Teams (PDTs) on larger product introductions.
• Complete general design-related calculations under supervision.
• Review patents relevant to assigned projects.
• Participates & contributes to risk management system as well as design control process.
• Conducts tests and writes test reports based on previously written test protocols of existing and new products under direct supervision.
• Independently manages prototype creation internally and externally.

Qualifications
• More than 5 years of mechanical design or related experience.
• Minimum 6+ years of experience with CAD software.
• Must have exceptional written and verbal communication skills to effectively work with supervisor and representatives from various departments as well as outside customers and contacts.
• Advanced knowledge of GD&T and drafting standards.
• Basic knowledge about FDA and CE mark registrations.
• Advanced knowledge of anatomy/physiology.
• Demonstrated report writing skills.

Duties/Responsibilities
• Research product designs, concepts, indications, intended use and competitive landscape for new and existing product lines independently.
• Develop and create design concepts, product designs, specifications, working models/prints, and related documents required by Acumed to produce products independently.
• Maintain existing product designs through NCRs, alerts, complaints and other associated documents.
• Expected to provide technical design/drafting mentoring and coaching to other product development employees.
• Function as a Product Development representative on cross-functional Product Development Teams (PDTs) on larger product introductions.
• Complete general design-related calculations under supervision.
• Review patents relevant to assigned projects.
• Participates & contributes to risk management system as well as design control process.
• Conducts tests and writes test reports based on previously written test protocols of existing and new products under direct supervision.
• Independently manages prototype creation internally and externally.

Qualifications
• More than 5 years of mechanical design or related experience
• Minimum 6+ years of experience with CAD software.
• Must have exceptional written and verbal communication skills to effectively work with supervisor and representatives from various departments as well as outside customers and contacts.
• Advanced knowledge of GD&T and drafting standards.
• Basic knowledge about FDA and CE mark registrations.
• Advanced knowledge of anatomy/physiology.
• Demonstrated report writing skills.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

International Marketing Manager Hillsboro, OR, USA Marketing Dec. 14, 2015

The Marketing Manager supports the achievement of revenue goals by developing strategies and programs to increase the adoption of on-market products and to optimize the launch of new products in partnership with Product Management. In order to ensure that the strategies and programs developed will be effective, the Marketing Manager conducts market research to understand targeted customer groups, industry trends and competitive strategies. By providing oversight over how Acumed's product marketing initiatives come together, the Marketing Manager will also work closely with the Marketing Communications team to ensure that all advertisements, PR, on-line promotional strategies, etc. align with the annual regional marketing plan.

Duties/Responsibilities
• The Marketing Manager aligns individual product marketing plans generated by Product Management to develop a marketing plan for their assigned region.
• Implements annual regional marketing plan and budget that effectively supports the sales organization achieve its annual revenue goal.
• Ensures marketing communications are coordinated, support marketing plan objectives and meet organizational expenditure requirements.
• Conducts primary and secondary market research to drive improved customer insights and understanding of industry trends, compiles and analyzes data for use by product management and sales. Refines marketing plan based on data analysis.
• Assesses competitive strengths and weaknesses and consolidates the data for use by product management.
• Using market research, helps define target customer and develops programs and tools that will facilitate the acquisition of new customers and the retention of current customers.
• Using market research, helps define and communicate Acumed vs competitive positioning to ensure market competitiveness.
• Supports new product launch priorities working with RBMs to define each product's Distribution Plan.
• Maintains relations with agents through frequent communication that helps us better understand their needs and how we can increase their focus on selling Acumed products.

Qualifications
• BA/BS in Business or related field required; Master's in Business Administration preferred.
• Minimum of 3 years of experience in marketing; at least 2 years of experience with medical products or medical devices highly preferred.
• Knowledge of business development principles related to strategic planning and resource allocation.
• Demonstrated track record of success in developing marketing plans and managing marketing processes.
• Demonstrated strategy, communication, and presentation skills.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Supplier Quality Engineer Hillsboro, OR, USA Supply Chain Jan. 08, 2016

The Supplier Quality Engineer (SQE) will primarily be responsible for conducting audits of practices at suppliers manufacturing plants and sites to ensure compliance to Acumed and ISO 13485 standards and FDA regulations.


Duties/Responsibilities
• Conduct Quality System Site Audits of existing or new Suppliers.
• Develop and implement Supplier quality evaluation systems. Including continuous quality assessment and monitoring.
• Manage supplier performance metrics (Scorecard). For suppliers that do not meet required levels, issuing Supplier Corrective Action Reports (SCAR) or other performance improvement initiate and ensure these are being completed as planned.
• Develop & implement plans to improve performance of business critical suppliers, which may include leading efforts to resolve recurring supply chain issues involving quality & delivery.
• Conduct and confirm follow up actions from supplier quality system audits.
• Responsible for Early Supplier Involvement. Coordinate with Engineering and Supply Chain Management to engage suppliers in design/process improvements in the concept phase of product development.
• Participate in New Product Development teams for qualifying new supply sources: this encompasses raw materials, components, sub-assemblies, assemblies, and service suppliers.
• Train other member of staff on QA specifications for suppliers.
• Lead teams in new supplier qualifications when need has been identified (i.e., outsourcing, opportunities, low cost country sourcing, existing supplier replacement).

Qualifications
• Bachelor's degree in Engineering, Quality Assurance, or equivalent technical education required.
• 5+ years' experience in manufacturing/ quality with a working knowledge of inspections techniques and procedures.
• Experience of working within the Medical Devices industry in a manufacturing environment.
• Experience of working to International Organization for Standardization (ISO) 13485 standards and conducting supplier audits
• Flexibility to travel to supplier sites
• Working knowledge of validation installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), process failure modes and effects analysis (FMEA) and failure analysis diagnosis.
• Able to analyze & present fact based management reporting with recommendations.
• Working knowledge of statistical tools (control charts, statistical process control (SPC), probability, and trending).
• Strong math and computer skills along with interpersonal, teamwork, decision making, problem solving, and root cause analysis and written skills (technical writing and presentation).
• Working knowledge of applicable Code of Federal Regulations (21 CFR Parts 7, 11, 803, 806,820, etc.) and ISO 13485 systems.
• ASQ certified Quality Engineer, (CQE) Certified Auditor Credentials, Six Sigma certified and knowledge of Lean Manufacturing principles desired.
• Detailed understanding of international quality systems (ISO, good manufacturing practices (cGMP), European conformity (CE), etc.).
• Demonstrated aptitude in data driven problem solving techniques. Skilled in root cause.
• Excellent written and oral communication skills.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Quality Engineer III Hillsboro, OR, USA Quality Jan. 11, 2016

A Quality Engineer III is responsible for quality planning and the overall quality of new products being released to the market. This role actively participates in product development activities, ensuring product and process conformance to global standards (including FDA and ISO 13485). The purpose of this position is to serve as a resource to product development and manufacturing to improve product quality, reliability, and process capability and facilitate teams in identifying, documenting, assessing, correcting and presenting quality issues using risk analysis and root cause analysis tools.


Duties/Responsibilities
• Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development
• Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.
• Collaborate with project teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
• Ensure quality and completeness of project design history files, validation packages, and change orders
• Provide ongoing quality engineering support throughout the product life cycle, including CAPA investigations, and design changes.
• Enhance and drive product risk management activities. Ensure identified activities and mitigations are executed as agreed.
• Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making; coordinate issue resolution using a risk-based approach
• Review verification and validation reports and identify gaps for cGMP compliance. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
• Provide consultation to end users and process owners with regard to data collection, analysis and creation of validation reports.
• Identify areas and opportunities to improve design and development process.
• Ensure product development and validation programs meet requirements of FDA and ISO
• Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
• Review all product labeling to ensure it is accurate and consistent with the Risk Management system.

Qualifications
• Bachelor's degree in an engineering or science discipline; advanced degree preferred
• 5-10 years of experience in quality assurance in a regulated environment. Direct experience working with implantable devices preferred.
• Three – 5 years of experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.)
• Experience with CAPA and failure investigation tools and techniques.
• Applied experience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.)
• Highly effective communicator, able to take action even when a position may be unpopular. Able to facilitate difficult conversations and negotiate solutions among different department representatives.
• Proven track record of strong team work and delivering results. Adaptable to fast-paced, dynamic work environment with shifting demands.
• Working knowledge of ERP Systems (SAP preferred) and Microsoft Office. Expert at Microsoft Excel.
• ASQ Certified Quality Engineer preferred.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Loaner Specialist Hillsboro, OR, USA Logistics Jan. 15, 2016

The Loaner Specialist follows complex, established procedures. Primarily responsible for maintaining customer relations by professionally and accurately entering in customer orders and complaints, shipping Loaner systems, and the quality and accuracy of Loaner inventory.

This is a great entry-level supply chain opportunity with benefits that include a competitive healthcare plan, 401(k) match, discretionary bonus opportunity, and much more.

General Duties/Responsibilities
• Communicate daily with customers and sales reps regarding billing issues or product requests.
• Generate customer orders, credits, debits, replenish and package Loaner inventory for outbound shipments.
• Perform cycle counts on Loaner inventory and execute inventory transactions in SAP to maintain accurate records.
• Gather documentation and complete various forms for resolution.
• Receive and record customer complaints professionally and accurately.
• Understand all department metrics and goals to support and participate in process improvements
• Cross-functionally assist all other areas of Logistics on an as needed basis
• Provide exceptional internal customer support.


Qualifications
• Minimum of High school Diploma or GED. Bachelor's degree preferred.
• Minimum of 1-2 years' customer service or warehouse experience required.
• High level of verbal and written communication skills supported by strong interpersonal skills and ability to work effectively within a close team structure.
• Must communicate with a positive and professional demeanor to maintain and improve customer relations.
• Computer literacy required and experience with MS Office suite preferred (Word, Excel, Outlook).
• Ability to work effectively under pressure, maintain composure and adhere to daily deadlines.
• Highly detail oriented with strong focus on quality assurance.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Clinical Research Specialist Hillsboro, OR, USA Clinical Studies Jan. 20, 2016

The Clinical Research Specialist (CRS) is responsible for the facilitating assigned research studies in accordance with established procedures and regulations. The CRS executes strategies for pre- and post-market clinical studies and facilitates operational and logistical tasks to ensure efficient clinical trials. Collaborates with VP, Quality, Regulatory, Compliance, and Project Management to ensure study activities occur in compliance with the appropriate regulations, including Food and Drug Administration (FDA) regulations, Investigational Device Exemption (IDE), 510 (k) guidelines, etc. The CRS coordinates resources for patient recruitment, trial site selection, and execution of trials with a focus on quality.


Duties/Responsibilities
• Facilitates and tracks compliance of review process to ensure Acumed and Investigator-initiated research projects are ethical, medically relevant, and scientifically valid.
• Serves as internal and external point of contact for daily activities of assigned Acumed or investigator-initiated research.
• Administers site compensation on assigned projects, ensuring compliance and deliverables are met.
• Monitors and reports metrics on assigned studies to assess research performance, including speed and effectiveness of contracting, start-up, training, recruitment, protocol adherence, data collection and reporting.
• Interfaces with investigators, clinical site personnel, Clinical Research Organizations (CROs), Institutional Review Boards (IRBs), and appropriate company personnel as required regarding research projects.
• Collaborates with Regulatory and Compliance team members to ensure research needs are met.
• Performs clinical trial site visits as needed to ensure regulatory and study compliance.
• Collaborates with other team members to coordinate the development and finalization of key study documents.
• Contributes to the development of relevant standard operating procedures.


Qualifications
• BS or BA in Quality Assurance, Regulatory Affairs, Clinical Research or related field required; focus in biological science or research or equivalent preferred. Advanced degree preferred.
• Minimum 1-3 years of experience in Clinical Research.
• Demonstrated awareness and understanding of positive ethical and moral principles consistent with clinical research and the mission and values of the organization.
• Knowledge of FDA and International Conference on Harmonization (ICH) regulatory requirements and general clinical research operations.
• Demonstrated independent judgment and decision-making skills with respect to functional responsibilities.
• Motivated to optimize clinical operations processes to meet deliverables.
• Ability to effectively work with teams and promote collaboration.
• Excellent verbal and written communication skills
• Adaptable to changing environments.
• Able to work in a fast-paced environment.
• Manage multiple projects simultaneously.
• High level of proficiency in MS Office.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Product Development Engineer II Hillsboro, OR, USA Product Development Engineering Jan. 22, 2016

The Product Development Engineer is responsible for development of a product from concept to commercialization. This includes research, planning, idea creation and realization, concept development, specification generation, maintenance of product designs, testing and validation protocols, as well as effective communication with team members, management, and customers.

Duties/Responsibilities
• Create and review draft project plans and provide feedback to ensure the plans are realistic and complete
• Create competitive product matrices for new and/or existing product lines
• Conduct tests, write protocols and reports
• Initiates Cad Labs for internal product development
• Create new designs with moderate complexity; drawings, models, define design requirements
• Collaborates with external design partners and vendors
• Develop presentations and present clearly to internal audiences (e.g. training events)
• Communicates effectively with Sales, Field Reps, suppliers and surgeons
• Make updates/modifications to existing SOP's/ Work Instructions
• Serve as the engineering resource for new product introduction teams
• Perform Design Control activities under supervision
• Write clinical data reports
• Review and approve drawings in ECOs, champion ECOs


Qualifications
• Bachelors in Mechanical Engineering, Bio-Mechanical Engineering, or Equivalent with 2-4yrs applicable experience*
• Competency in communicating anatomy/physiology (A/P).
• Basic understanding of GD&T and able to apply GD&T principles in technical drawings
• Ability to design solutions to simple problems and/or portions of a larger system.
• Ability to read and understand patents.
• Ability to read and understand FDA and ISO requirements
• Ability to conduct testing and writing protocols and reports under limited supervision
• Applied knowledge of 3D/2D software, ability to model and create drawings of moderate complexity for plates, screws, etc. Ability to review and approve drawings in ECO's, ability to champion ECO's
• Basic understanding of Design Control
• Ability to read and understand medical journal articles and present data effectively to peers and perform clinical summaries and write clinical data reports.
• Ability to conduct in depth literature searches and create a competitive product matrix

Acumed is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Corporate Account Executive Hillsboro, OR, USA Major Accounts Jan. 28, 2016

The Corporate Account Executive (CAE) develops new business in corporate accounts, drives contract compliance in the corporate accounts, and works with the sales team to develop strategies to grow corporate account business. Utilizes analytical, interpersonal, and critical thinking skills to develop and maintain strong working relationships with administrative, contracting and clinical leaders at assigned accounts, presenting Acumed as the solution to their problems.

Duties/Responsibilities
• Establish relationships with pertinent supply chain personnel, including heads of contracting and value analysis and maintain key decision maker contact lists.
• Close new business deals by coordinating requirements, responding to RFP's, developing and negotiating contracts, and integrating contract requirements with business operations.
• Act as key point of contact for Corporate Offices of assigned clinical facilities, IDNs and GPOs, supporting all contract and service related issues across the Acumed business, including:
• Facilitates resolution of customer product issues and concerns
• Ensures adherence to contract compliance
• Act as a content expert on corporate contract portfolio of assigned accounts, supporting field teams with strategies to optimize existing agreements
• Serve as a key member of the sales team who contributes to strategic direction by developing, making recommendations and implementing account strategy with corporate accounts
• Oversee all product conversion opportunities by coordinating resources, providing analytics and reporting regularly on progress both internally and externally.
• Represent Acumed in supply chain meetings and be the conduit to the sales organization for opportunity analysis.
• Assist in the preparation and operation of customer site visits, trade shows, conventions, and/or clinical meetings
• Routinely update/engage local sales team from rep to manager on business status changes and pending strategies
• Maintain routine communication with sales forces to both gather information as input to development of account strategy and share information gathered from account
• Analyze and interpret sales and trend data to develop targeted action plans

Qualifications
• BA/BS in Business or related field highly preferred, equivalency in experience required.
• 5+ years' experience in medical device sales and/or national accounts management.
• Solid understanding of US Business Practices and markets management related to medical device sales.
• Strong negotiation and sales skills.
• Ability to determine which company resources are needed to effectively win selected national account contracts and facilitate and coordinate those resources as required.
• Strong presentation skills, written and verbal, to both hospital and national account customer administrative and clinical audiences.
• Strong interpersonal and relationship management skills, demonstrated ability to interact with other professionals to gather and disseminate information.
• Strong attention to detail, tolerance for time sensitive deadlines and the ability to manage multiple priorities.
• Proven track record in prospecting and relationship development with IDNs, GPOs, etc.
• Ability to create and maintain training documents and procedures. Ability to create graphics and integrate screen-prints into documents.
• Computer literacy is required. Strong working knowledge of ERP systems, MS Office (Word, Excel, Outlook).

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Environmental Health and Safety Manager Hillsboro, OR, USA Safety Jan. 28, 2016

The Environmental Health and Safety Manager (EHSM) creates, implements, and coordinates environmental health and safety programs and policies in accordance with local, state and federal regulations to prevent or correct unsafe and hazardous working conditions. The EHSM ensures proper execution of EHS training programs throughout the organization. The EHSM develops and maintains EHS records and reports as required and in accordance with established guidelines and regulations. The EHSM provides guidance, awareness, proactive leadership and solutions to ensure safe and hazard-free working conditions.

Duties/Responsibilities
• Develops, implements, and monitors environmental health and safety systems, policies, and procedures including the Company's Emergency Response Plan.
• Promotes safety policy and program compliance by leading and conducting inspections, establishing and reporting on metrics, and coaching leaders and employees.
• Performs risk assessments in labs, offices, and manufacturing areas, and recommends/implements appropriate safety practices.
• Reviews all incident, injury and illness reports, investigates root cause, and makes appropriate recommendations to management to eliminate future exposure.
• Develops and implements accident investigation techniques, data analysis, trends and proactive preventative programs and procedures.
• Identifies and anticipates environmental health and safety hazards by surveying operational and occupational conditions, providing recommendations on new equipment and procedures, investigating violations and recommending preventive programs.
• In collaboration with the Training & Development team, drafts training content for New Hire Safety Orientation, Lab Safety, Biological Safety, OSHA, Oregon OSHA, Chemical Safety, Bloodborne Pathogens, Safety Data Sheets, Global Harmonized System for Hazard Communication, Shipping Hazardous Materials, (DOT/IATA), Personal Protective Equipment, Ergonomics, and other trainings for EH&S compliance.
• Oversees and coordinates the activities of the Safety Committee to ensure OSHA requirements are met.
• Oversees and ensures compliance of the Company's Radiation Safety Program.
• Participates in Occupational Safety and Health Administration (OSHA) inspections, provides inspectors with appropriate documents and identifies safety measures.
• Manages all operational waste streams including identifying opportunities to reduce costs and minimize waste across all biological, hazardous, and universal waste streams and service providers.
• Develops safety campaigns and communications that are consistent with Company safety objectives. Organizes and executes Company safety reminders.
• Organizes fire drills, security tests, policy reviews, annual safety meetings, etc.
• Maintains proficiency in best practices, standards, guidelines, and regulatory changes established by OSHA, OR-OSHA, EPA and DOT.
• Promotes a safe environment by coordinating and cooperating with local, state and regional safety groups and agencies; acts as liaison with the Hillsboro Police Department, Tualatin Valley Fire and Rescue, OSHA, and other federal, state, and local agencies.
• Assists with the development and auditing of the annual safety budget and properly administers expenditures.

Qualifications
• Bachelor's degree in Industrial Safety, Environmental Safety, Biology, or a related field plus 5 years of experience or an equivalent combination of education and experience.
• 5 or more years of experience in a health and safety related role in a manufacturing environment required.
• Working knowledge of applicable Environmental, Safety, Health, and Training regulations including health physics.
• Knowledge of safety principles, methods and techniques needed to define, control and eliminate unsafe physical conditions, equipment and machine hazards and risks.
• Ability to recognize potential and active high-risk situations and to formulate and advocate corrective and/or preventative measures. Ability to respond well to emergency situations.
• Professional certifications (OSHA, Certified Safety Professional, Certified Industrial Hygienist, Lean Certification, and HAZWOPER) preferred.
• Knowledge of organic chemistry, especially halogenated hydrocarbons, is preferred.
• Well-organized, detailed and customer (internal and external) oriented self-starter. Ability to manage multiple projects of varying priorities simultaneously.
• Ability to exercise sound judgment, work well independently, prioritize duties and follow through tasks to completion.
• Excellent interpersonal skills, verbal and written communication (ability to interface with personnel, outside contractors and different functional groups within the business). Ability to lead, manage and motivate employees in a safety environment.
• Strong problem solving, organizational and analytical skills. Ability to conduct detailed analytical research into problem areas and special requests.
• Skilled and experienced in using Microsoft Windows, Advanced Excel, Word and database programs.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

CNC Machinist II (swing shift) Hillsboro, OR, USA Production Jan. 29, 2016

The Machinist produces medical devices using manual and CNC equipment while ensuring product is loaded and unloaded correctly per standard operating procedures. This is a great Machinist opportunity that offers a robust benefits package, a 401k plan, and a generous Paid Time Off program!

Shift: Swing Shift M-Th 3:00pm - 1:30am

Work Location: Cornelius Pass Screw Cell

Duties/Responsibilities
• Under close supervision, efficiently operates production machine tools to maintain Quality, Cost and Delivery.
• Starts and observes machine operation to detect malfunctions or out-of-tolerance machining.
• Visually inspects surfaces for flaws and smoothness.
• Empties chip bins.
• Sweeps and cleans work area and equipment.
• Use established practices to ensure Quality during operation including documentation and techniques.
• Monitor machine performance.
• Perform preventative maintenance as required.


Qualifications
• Generally requires 2-4 years related experience.
• General set-up competency on Cell specific Machine Tools.
• Demonstrated troubleshooting skills and basic programming understanding.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Engineering Internship - Summer 2016 Hillsboro, OR, USA Engineering Feb. 04, 2016

Acumed is looking for an Engineering Intern to join our new product development team! This is a great opportunity for students interested in gaining experience in the medical device industry as well as exposure to other vital company systems, such as manufacturing and quality departments.

Must be a current student in order to apply.


Duties/Responsibilities
• Aid the engineers in the creation of complete working drawings and related documents required by Acumed to produce product
• Learn about and aid the maintenance of existing product designs through ECOs, NCRs, drawing revisions, engineering master revisions, etc.
• Keep an up-to-date project list
• Record detailed design notes of product development
• Complete general engineering calculations
• Communicate well with supervisor and other company personnel

Qualifications

• Must be a current student in Engineering during the course of the internship. Completion of sophomore year preferred
• Ability to read and speak English sufficiently to read, understand and complete all paperwork
• Experience with mechanical design preferred
• A basic knowledge of GD &T and basic drafting standards preferred
• Some CAD experience or equivalent preferred
• Basic computer skills required, MS Office

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Accounts Receivable Supervisor Hillsboro, OR, USA Accounting - AR Feb. 10, 2016

The Accounts Receivable Supervisor (ARS) uses knowledge of accounting practices, current regulations, and systems used at Acumed to oversee, evaluate and direct resources to maintain effective collection processes, internal controls and accurate reporting. The ARS minimizes collection risk of accounts receivable and ensures timely and accurate workflow of accounting transactions and reporting. The ARS provides technical support to direct reports and other members of the Accounting department. Responsibilities include reviewing, troubleshooting, and resolving and issues to ensure reliability of transactional and financial processes.

Duties/Responsibilities

• Direct and coordinate the daily operations in accounts payable, accounts receivable, payroll, credit card and expense report processing, sales tax reporting, aggregate spend reporting and commissions
• Guide and support staff in handling difficult or complex problems
• Review/approve transactions, properly maintaining general ledger, cost center and internal order structures in SAP as needed
• Support month end close processes, ensuring the completeness of accounting records
• Ensure GL accounts are reconciled and reviewed monthly, including resolution of outstanding items as assigned
• Prepare routine and ad hoc financial reporting and analysis, identifying trends and opportunities for improvement
• Assist in preparing annual budgets
• Prepare schedules and support for annual audit and tax return processes
• Participate in the development and review of accounting policies, procedures and work instructions
• Instruct and train Accounting personnel on proper accounting and SAP procedures
• Implement process improvements in alignment with the company's and the department's strategic goals

Qualifications
• BA/BS degree in accounting or related field plus 5 years' experience or equivalent combination of education and experience required.
• 5+ years' experience in accounting-related role required, with a minimum of 2 years' experience with accounts receivable.
• SAP experience preferred; 2+ years' experience with accounting software required.
• Prior supervisory experience strongly preferred.
• Strong knowledge of GAAP, including basic accounting concepts, practices and procedures
• Strong organizational skills in order to prioritize, supervise and complete work efficiently
• Ability to independently conduct research and exercise judgment when resolving issues
• Excellent verbal and written communication skills in English, including the ability to interact with all levels of personnel
• Ability to effectively coach and mentor others
• Flexibility to adapt to changing priorities
• Attention to detail with an eye for accuracy
• Motivation and persistence to complete critical tasks in a timely manner
• Advanced computer skills including MS Excel, with experience in transactional systems
• Ability to operate office equipment including multi-line phones, personal computers and copiers

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Product Management Internship (MBA) - Summer 2016 Hillsboro, OR, USA Product Management Feb. 10, 2016

The MBA Internship is designed for high-potential students who have completed at least the first year of an MBA program. The intern will gain valuable on-the-job experience as a member of Acumed's Product Management team and exposure to the medical device industry.

A successful intern will participate in solving real-world challenges in a fast-paced environment. The intern will gain a broad view of the organization and exposure to key financial and business systems while developing an understanding of how to manage a complex global product portfolio. The intern will research, analyze, and present findings for a major project initiative across this 90-day program.

Potential candidates must have the desire to learn and ability to apply relevant market scoping and business analytics tools. Candidates must be motivated, high-potential performers who demonstrate the ability to influence and effectively lead others to achieve business results.


Qualifications
• First year of MBA program completed
• Strong market research and analytical capabilities
• Ability to influence others effectively to achieve desired business results
• Strong interpersonal/communications skills
• Ability to build relationships and collaborate with associates at all levels of the organization
• Ability to work independently within sensitive time constraints

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.