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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 Passes
  • Reduced Costco Membership Fees
  • Reduced Gym Membership Fees
  • An Employee Referral Program
  • Bike Room and Showers

Current Open Positions

Position Location Department Posted Onsort descending
Production Supervisor Hillsboro, OR, USA Production Apr. 15, 2014

Overview

The Production Supervisor is responsible for providing leadership and support to cell members. Facilitates constructive communication and builds teamwork. Leads the cell teams toward achieving objectives for quality, delivery, and cost.

General Duties/Responsibilities

  • Primary responsibility is to provide support and direction to the cell team. This requires spending up to 40 percent of the average workday in the cell, interacting in person and building rapport with team members.
  • Work with team members to set measurable goals. Ensure that team objectives and efforts are aligned with the company's current strategies and priorities.
  • Provide training and tools team members need in order to grow professionally and achieve their goals.
  • Promote a customer focus in the cell.
  • Ensure that cell processes are managed and adhered to. Monitor key performance metrics to ensure constant improvement and waste reduction.
  • Promote and support continuous process improvement activities. Identify constraints and make sure cell members are aware of these and are working to eliminate bottlenecks.
  • Work with Process Engineers to standardize processes and maintain a smooth workflow.
  • In preparation for annual performance appraisals, follow up on progress with each cell member at least quarterly, and revisit/adjust goals as necessary.
  • Work proactively with other cells, and provide support as needed, to ensure that customer needs are met.
  • Build productive working relationships with internal and external customers (i.e. planning, quality assurance, outside vendors...)
  • Facilitate and actively participate in group team building activities.
  • Make sure that cell teams meet regularly, and provide guidance/support as needed.
  • Support new product introduction activities
  • Monitor capacity in the cell(s). Make sure they have the resources to accomplish the work in the most efficient manner possible.
  • Develop documentation to procure equipment - Authority for Expenditure (AFE) and Return on Investment (ROI).
  • Set a standard for proactive (rather than reactive) processes and decision-making.
  • Promote safety within the shop.
  • Other job related duties as assigned.

Qualifications

  • Minimum 3 years of supervising a team (preferably in a production environment), or equivalent education/ experience in a similar capacity.
  • Good supervising skills and ability to motivate others to work as a team towards a common goal
  • Excellent organizational skills with extensive knowledge of MS Office (i.e. Excel, Word, Outlook)
  • Demonstrated accountability / time management. Must follow through with commitments and adhere to deadlines.
  • Ability to read and speak English sufficiently to read, understand and complete all paperwork.
  • Knowledge of MRP system to be able to enter electronic transactions.
  • Self-motivated; able to work with little supervision.
  • Track record of developing and empowering employees.
  • Extensive knowledge of Lean Manufacturing concepts and techniques.
  • Reliable, dependable and honest.
  • Experience working in a regulated environment.
  • Knowledge of all Acumed products and processes.

To apply, please visit our applicant registration page

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

Quality Manager Hillsboro, OR, USA Quality Jun. 17, 2014

Overview

Provide leadership and direction in the implementation of Quality policies, procedures, and strategies, as well as prevention-based quality improvement programs.   The Quality Manager ensures that policies and procedures of the organization comply with all applicable laws and regulations.  Develop, implement, and maintain the Acumed quality system in compliance with applicable regulations.  Enhance customer satisfaction through the delivery of high-quality medical devices, promote continuous improvement culture and ensure compliance with applicable regulations. 

Duties/Responsibilities

  • Build successful teams, develop and lead people to achieve continuous quality improvement and drive change.
  • Develop and implement quality system management in alignment with the Company's long term strategy.
  • Educate non-experts, internally and externally, on complex quality topics.
  • Develop and maintain a system to measure performance against established standards.
  • Assess, report, and implement new and changing regulations or the addition of new markets to the quality system.
  • Approve post-market surveillance communications prior to submission and distribution
  • Plan and manage departmental activities in accordance with annual operating budget including capital expenditures.
  • Drive overall quality of Acumed's products and processes to ensure a satisfied customer. 
  • Ensure Acumed's products are of the highest quality, lowest risk and greatest benefit to the customer.
  • Ensure all product designs are developed in compliance with the regulations of the markets in which we sell product. 
  • Develop and maintain quality policies and ensure efficient use of Quality Engineering.
  • Assure engineering design processes and manufacturing processes are conducted in compliance with Acumed policies and procedures.
  • Ensure the health of the Acumed Quality System through:
    • Quality data analysis
    • Effective Post-Market Surveillance
    • Compliance with global adverse event/vigilance reporting requirements
    • A robust Corrective and Preventive Action (CAPA) System
    • An active and engaged Internal Audit Program
  • Host external auditors and present the Acumed Quality System in the best light. 
  • Assure all Acumed employees receive sufficient training in the elements of the Quality System and its implementation at Acumed. 
  • Ensures system is compliant with all applicable regulations including those issued by FDA, SFDA, JPAL, etc.
  • Champion the quality system management strategy within the organization to gain compliance and commitment at all levels from the executive team to the shop floor.
  • Ensure quality metrics are adequately captured, analyzed and provided to company leadership for improvement activities.  Lead Management Review activities.
  • Direct and supervise employees responsible for Document Control, Post-Market Surveillance, Corrective & Preventive Action, Field Action, Management Review, Performing Internal and Managing External Audits, and Quality System Software Validation.

Qualifications

  • Bachelor's degree in an engineering or science discipline; advanced degree preferred
  • 7-10 years of experience in medical device manufacturing
  • 5 years of experience in quality leadership role
  • Extensive knowledge of Quality System Regulation, US FDA, and ISO 13485.  Experience with international quality system regulations (JPAL, CFDA, Health Canada, ANVISA, etc) is ideal. 
  • Proven problem-solving skills and the ability to train teams to resolve various issues using available tools.
  • Familiarity with Lean Manufacturing concepts.
  • Knowledge and experience with ERP systems, preferably SAP, and its application in a quality-system environment.
  • Exceptional organizational skills with extensive knowledge of MS Office (i.e. Excel, Word, Outlook)
  • Self-motivated, able to work with little supervision.
  • Excellent leadership skills and ability to motivate others to work as a team towards a common goal, and a strong balance of strategic and tactical approaches, team building, training, coaching and development.
  • Proven success in executing improvement plans and activities that achieve expected results.
  • Strong verbal and written communication skills
  • Ability to communicate at all levels of the organization in order to influence change and drive system improvements to meet customer requirements.
  • Ability to read and speak English sufficiently to understand and complete all necessary documentation

To apply, please visit our applicant registration page

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

Sales Trainer Hillsboro, OR, USA Medical Education Sep. 01, 2014

Job Purpose/Scope
The Sales Trainer conducts a wide range of training engagements including on-site and in-field sales training courses. Sales training courses will incorporate classroom, live video, and taped webinar sales support detailing effective sales techniques focused on Acumed’s strategic sales initiatives. Additionally, the Sales Trainer will provide the field sales organization learning outcomes driven by integrating sales methodologies, increasing market penetration, developing selling acumen, competitive insights, and product sales advantages to create confidence and excitement in choosing Acumed orthopaedic solutions. This position will support the Medical Education and Training Team Manager in the creation and execution of sales training and development plan.

General Duties/Responsibilities

  • Creates and delivers sales training content to the Acumed field sales organization focused on increasing product placement and selling skills.
  • Regularly assesses the sale force training needs by observing individual account manager’s performance/ behaviors and collaborates with the Medical Education and Training leadership to mitigate these needs.
  • Participates in strategic projects designed to fulfill the needs of the field Sales Force. These projects include continuous collaboration with all relevant support departments: Marketing, Regulatory, Product Management, Sales and include but are not limited to new product launches, new marketing directives, new indication launches and new positioning directives.
  • Analyzes and assesses sales training effectiveness to determine when revisions, enhancements, or new programs should occur and receives recommendation/input from team. Provides input to Medical Education and Training leadership.
  • Reviews department reports, sales trainee evaluations to evaluate the effectiveness of training feedback. Initiates continuous improvement plan based in response to this feedback.
  • Develops evaluations to measure training effectiveness and provide metrics for management review.
  • Acts as main point of contact for day to day operations related to development of new training initiatives or supporting changes in direction.
  • Oversee and manage on-site cadaveric lab usage. Implement business plan for leveraging the cad lab’s strategic future in sales training and other sales interests.

 

Qualifications

  • Minimum BS/BA/RN degree
  • 5+ years orthopaedic/healthcare commercial experience in sales, marketing, training, or related experience
  • 2+ years of orthopaedic training/teaching experience
  • Ability to develop/facilitate training classes/workshops
  • Excellent communication/presentation skills (both oral and written)
  • Demonstrated ability to work effectively both independently or in a team
  • Proficiency with Microsoft Office software (e.g. Power Point, Word, Excel)
  • Excellent planning and organization skills
  • Solid understanding of Acumed products and their surgical applications
  • Discretion, confidentiality and ability to build strong, trusting relationships
  • Solid understanding of global healthcare policies, trends and compliance issues
  • Conversational Spanish language skills, preferred

To apply, please visit our applicant registration page

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

Senior Regulatory Specialist Hillsboro, OR, USA Regulatory Sep. 18, 2014

Overview
The Senior Regulatory Specialist 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 compentent authorities. In additon, 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 maintaned 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
• Masters of Science in Regulatory Affairs, Biology, Chemistry, Engineering or related field required and 5+ years direct experience or Bachelor's degree and 7+ years of experience
• 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.

US Business Services Specialist Hillsboro, OR, USA Customer Service Oct. 06, 2014

Overview

First of three levels of US Business Services. USBS Specialists receive questions from customers and follow established procedures to provide answers or refer calls to appropriate staff. Works with Level 2 and 3 USBS representatives to ensure that good customer relations are maintained, and complaints are resolved fairly and effectively, and in accordance with Acumed procedures. Assists senior and lead staff on order status, product information, account status, pricing, product or service. Works under close supervision of US Business Service Leads and follows established procedures.


General Duties/Responsibilities
• Professionally handle incoming requests
• Ensure that issues are resolved both promptly and accurately
• Thoroughly and efficiently gather customer information
• Resolve billing issues and shipping discrepancies
• Gather documentation and complete various forms for resolution
• Efficiently and accurately enter customer orders
• Provide quality service and support in a variety of areas
• Receive and record customer complaints professionally and accurately
• Other job-related duties as assigned


Qualifications
• High School diploma required. (Associates or bachelor's degree preferred)
• Minimum of 1-2 years customer service experience required
• Exceptional people skills – project a positive, professional image at all times
• Excellent verbal, written and telephone skills supported by strong interpersonal skills and ability to work within a team structure
• Ability to work under a high stress environment, maintain composure and adhere to daily deadlines
• Effectively resolve problems and answer questions in a clear and concise manner
• Ability to multi-task (i.e. simultaneously answer multiple phone calls and process orders) and manage time effectively

To apply, please visit our applicant registration page

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

Administrative Assistant/Receptionist Hillsboro, OR, USA Human Resources Oct. 10, 2014

Job Purpose/Scope

The Administrative Assistant/Receptionist (AAR) performs a wide range of administrative tasks and support duties as assigned including answering phones and directing phone and in –person requests for information, preparation of internal correspondence, scheduling and coordinating travel, organizing and scheduling meeting and calendar requests, mail processing, and departmental meeting and project support.  The AAR provides clerical and administrative support to the VP, HR and other executives and department leaders as required.

Qualifications

• High school diploma or equivalent required plus 2+ years general office or administrative experience
• Must be organized and flexible with ability to multi-task and prioritize work.
• Excellent grammar, punctuation, and spelling required.
• Ability to use MS Office Word, Excel, and Powerpoint required.
• Ability to arrange travel and submit expense reports required.
• Exemplary interpersonal and communication skills.
• Knowledge of use and operation of standard office equipment.
• Ability to follow detailed directions.
 

To apply, please visit our applicant registration page

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

Finisher (Day Shift) Hillsboro, OR, USA Production Nov. 05, 2014

Overview

Under general supervision, the finisher finishes products according to approved prints through means of tumbling, deburring, polishing and/or blasting processes.

Day Shift (5:00am - 3:00pm)


General Duties/Responsibilities

• Maintain Acumed's high quality standards. Know, understand, and follow all SOP's and WI's.
• Continual focus on customer service (Quality, Cost & Delivery), lean manufacturing concepts, and process improvement activities.
• Accurately and thoroughly complete appropriate paperwork, and computer transactions with minimal supervision.
• Conduct preventive maintenance on finishing equipment with general supervision.
• Assist with monitoring supply levels – inform appropriate personnel when supplies are low.
• Complete individual finishing projects (tumbling, deburring, polishing and blasting).
• Be proactive and promote a safe working environment. Keep work area clean and organized.
• Cross-train, coach and mentor cell members as assigned.
• Other job-related duties as assigned.


Qualifications

• High School Diploma/GED or equivalent.
• Experience in metal finishing (hand and machine) and media blasting preferred but not required.
• Experience with machine operation preferred but not required.
• Basic mechanical aptitude, good hand-eye coordination, and detail-oriented.
• Ability to read and understand blueprints. Basic math skills.
• Self-motivated and able to work with minimal supervision, work independently or in a team environment.
• Prompt and regular attendance.
• Reliable, dependable and honest.

To apply, please visit our applicant registration page

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

Medical Education Program Manager (2 Open Positions) Hillsboro, OR, USA Medical Education Nov. 05, 2014

Job Purpose/Scope

Under general supervision, the Medical Education Program Manager position coordinates efforts with the Medical Education Manager in supporting the development of all Acumed medical education curriculum, educational tools, presentations and materials. Work includes collaborating and implementing platforms for group instruction, lectures, demonstrations and workshops to inform and improve surgeon educational programs under the supervision of the Medical Education Manager. The Medical Education Program Manager will design of educational courses based on clearly defined curriculum objectives to better meet the needs of surgeon attendees and faculty.


Qualifications

• Bachelor Degree in science, communications, education or equivalent
• 2 years of events, marketing, or education experience required
• 2 years of medical device experience preferred
• Proven ability to train and educate; passion for learning.
• Excellent writing, oral communication and presentation skills.
• Proven ability to communicate complex material in a simple, straight forward, easily understood presentation.
• Competency in creating PowerPoint presentations and utilizing Excel spreadsheets for activity tracking.
• Solid understanding of Acumed products and their surgical applications preferred.
• Strong interpersonal skills.
• Ability to work collaboratively and independently in a cross-functional and team oriented environment.
• Strong working knowledge of MS Office Suite (Word, Excel, PowerPoint, Outlook).
• This position will require a significant amount of travel (30%).

To apply, please visit our applicant registration page

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

Project Manager Hillsboro, OR, USA Project Management Nov. 05, 2014

Overview

Using independent judgment, plans, manages and executes several simultaneous new product development projects from initiation through project close. Evaluates projects according to predetermined timelines and budgets. Ensures quality control throughout the project life cycle.

Duties/Responsibilities

• Lead cross-functional project teams (Product Development Teams). Facilitate communication and interaction amongst the functional representatives.
• Coordinate project priorities with cross-functional management and coordinate overall project launch logistics with Operations team.
• Coordinate and track project against schedule and budget of New Product Introduction, oversee all aspects of projects with PDTs, and ensure projects meet goals and are completed on time and within budget.
• Set deadlines, assign responsibilities, and monitor and summarize progress of projects.
• Lead the work of others assigned to projects from various departments.
• Prepare reports for upper management regarding status of projects and coordinate the preparation Acumed Product Lifecycle documentation.
• Develop and implement recovery plans when projects get off track (i.e. scope, budget, or schedule).
• Work with other Program and Project Managers to continuously improve NPI processes to make product development and launches more efficient and provide visibility across teams of project needs, conflicts, and constraints.
• Ensure any risks and issues that may impact the schedule are identified and resolved quickly, and are escalated to the appropriate stakeholders if there will be an impact to the scope, schedule, or budget. Provide options for mitigating impact.


Qualifications

• Bachelor's degree required with a preference for a BS degree in Mechanical, Manufacturing, Industrial Engineering or related field.
• 3-5 years of experience of medium to large complex project management in product development and/or manufacturing.
• CAMP (Certified Associate in Project Management) and /or PMP (Project Management Professional) preferred.
• Experience with MS Project (or equivalent project management software) to manage project schedule, tasks, and resources.
• SAP experience highly desirable.
• Familiar with standard concepts, practices, and procedures in the medical device field or related area preferred.
• General knowledge of finance, including ability to read and understand financial data such as product income statements, return on investment analysis.
• General knowledge of marketing, including market research, sizing, pricing, marketing communications and product launch.
• A wide degree of creativity and latitude is expected and excellent communication skills, both written and oral are required.
• Solid interpersonal skills to interface with co-workers, customers and vendors at all levels.
• Ability to manage specific tasks to completion with minimal direction.
• Demonstrated ability to mentor, develop and influence others.

To apply, please visit our applicant registration page

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

Portfolio Manager, Trauma Hillsboro, OR, USA Product Management Nov. 10, 2014

Job Purpose/Scope
Responsible for multiple product portfolios, including the development and management of product vision, portfolio strategy, product development roadmaps, and strategic programs. The Portfolio Manager is responsible for setting short-, mid-, and long-term portfolio goals and developing plans to meet these goals in collaboration with Sales, Management, and Senior Product Managers. Responsible for financial forecasting, staffing, resourcing, and budgeting for the Portfolio group. Ensures portfolio strategy is aligned with overall corporate growth objectives. Responsible for hiring, managing, developing, and coaching Product Management team including Senior Product Managers and Product Managers.


Duties/Responsibilities
• Lead Portfolio group by guiding and formulating product and target market strategies; continuously oversees the execution of strategies and drives the portfolio to align with long-term corporate growth objectives.
• Provide leadership and coaching to the Portfolio group and is responsible for furnishing them with the resources, tools, and uniform processes to grow their respective product portfolios.
• Responsible for balancing Acumed's strategic goals with long-term market trends and opportunities, and ensuring each product and strategy within the portfolio meets the voice of the customer.
• Direct Senior Product Managers in developing their long-range strategic plan and assist in the launch planning of products to fulfill the long-term portfolio vision.
• Responsible for conducting global market and industry analysis. Identify, collect and analyze market trends, market share, sales trends, and customer needs. Advise Senior Product Managers of trends in the marketplace when suggesting new products or product enhancements.
• Guide Senior Product Managers in preparing long range, annual, and quarterly forecasts for each product within the portfolio. Review product line forecast with key internal stakeholders and builds strategies to meet expectations set within the product line forecast.
• Recruit, train, and supervise Senior Product Managers and Product Managers. Ensure applicable policies and procedures are understood and followed.
• Responsible for Portfolio group resource allocation for travel, internal projects, tradeshows, and training events.
• Creates and manages Product Management Selling, General, & Administrative budget for assigned Portfolio.
• In conjunction with Sales Management, develop and manage sales budget for product lines through SAP and reports on monthly basis.
• Participate in conventions and professional exhibitions to develop and maintain customer relationships and to remain aware of product requirements and new market opportunities.
• Manage feedback from field regarding Acumed product and enters data into product feedback database and the Acumed complaint system.
• Lead, support and participate in continuous improvement activities.


Qualifications
• BA/BS in product management, product marketing, or related field required
• 10+ years product management experience preferred
• Background in orthopedic products or medical devices required
• Strong interpersonal, supervisory, and relationship management skills
• Ability to work collaboratively and independently in a cross-functional team oriented environment
• Strong verbal and written English skills (both in groups and one-on-one interaction)
• Strong analytical skills and ability to deliver results with multiple and complex projects
• Previous management experience and demonstrated leadership ability 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.

Corporate Account Executive Hillsboro, OR, USA Major Accounts Nov. 11, 2014

Overview
Utilizes a wide array of 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. 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. This is a field-based position.

General Duties
• 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:
• 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
• 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 national accounts.
• Strong negotiation and sales skills.
• Ability to determine which company resources are needed to effectively win selected national account contracts and effectively facilitate and coordinate those resources as required.
• 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.

To apply, please visit our applicant registration page

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

Senior Quality Engineer Hillsboro, OR, USA Quality Nov. 11, 2014

Job Purpose/Scope

This position has the responsibility and authority to provide Quality Assurance Engineering representation to Product Development teams. This position owns the risk management profile for products during their entire lifecycle, including risk identification, completion, and management of risk mitigation activities. Participates in facilitation of initial product design, development, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness. Coordinate feedback of quality indicators and statistics to organization for use in business decisions. Partner with Operations and Engineering in process improvements.
Responsible for quality planning and the overall quality of new products being released to the market through participation in product development to ensure product and process conformance to global standards (including FDA and ISO 13485). Performs, directs, or consults in process and design validations. Provides QA approval for changes to design, test methods, and test equipment to assure the design and production of medical devices are in compliance with applicable standards. Drives investigations, corrective action implementation, and corrective action verification activities as assigned.
Position is also responsible to aide in the identification, documentation and subsequent testing of all design requirements identified by all internal and external customers, including end users, purchasing organizations, and regulators.

Duties/Responsibilities
• Provide quality leadership in product development teams to the entire design lifecycle of Acumed products to ensure compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485. The design lifecycle includes design control, design verification and validation, design transfer, process validation, risk management, and specification development.
• Coordinate with Regulatory staff members to ensure that product testing and design requirements for intended markets are identified, part of the product requirements as documented in the Design History File, and met during the product development. Represent the needs of the Regulatory team during product development.
• Guide teams to ensure robust application of appropriate design and manufacturing controls.
• Educate project teams on requirements related to regulations, procedures, and requirements. Provide training, guidance and interpretation.
• Ensure quality and completeness of project design history files, risk management files, validation packages, and change orders.
• Provide ongoing quality engineering support throughout the product life cycle, including risk management, design and manufacturing changes, and CAPA investigations.
• Lead all risk management activities for products throughout their lifecycle, including risk identification, completion, and management of risk mitigation activities.
• Be a strong representative for Quality and Regulatory concerns during technical discussions and risk-based decision making; ensure issues are resolved using a risk-based approach.
• Monitor the quality and performance of new products to ensure requirements are met and product is performing as anticipated. Identify concerns, develop a risk-based solution with impacted departments and lead implementation efforts, as appropriate.
• Drive the creation and approval of verification and validation reports and identify gaps for compliance with Acumed policies and global regulations. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
• Deliver appropriate quality metrics to the organization to identify opportunities and drive improvements. Consult with end users and process owners on data collection, analysis and reporting.
• Identify opportunities, develop solutions, and support implementation of improvements to the design and development process. Support continuous improvement efforts.
• Report status updates on assigned responsibilities and goals; timely escalation of issues
• Other activities as assigned.

Qualifications

• Bachelor's degree in an engineering or science discipline; advanced degree preferred
• 5-7 years of experience working in quality assurance role in a regulated environment. Experience working with implantable devices preferred.
• Experience applying quality regulations and standards (e.g. 21 CFR 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, Six Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.)
• Knowledge of ERP Systems (SAP preferred) and advanced Microsoft Office; expert level Microsoft Excel skills.
• Certified Quality Engineer (or equivalent) preferred.

To apply, please visit our applicant registration page

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

Senior Packaging Engineer Hillsboro, OR, USA Engineering Nov. 17, 2014

Overview

The Packaging Engineer is responsible for packaging, product delivery and labelling solutions for medical devices from concept to commercialization. The Packaging Engineer works closely with Product Engineering, Product Management, Quality and Supply Chain teams to produce robust and cost-effective solutions that meet market and regulatory needs. Responsibilities include implementing new packaging, product delivery solutions, maintenance of existing packaging/ product delivery solutions/ labelling, testing and validation, and effective communication with team members, management and customers.


Duties/Responsibilities
• Review draft project plans and provide feedback to ensure the plans are realistic and complete
• Research product designs, indications, intended use(s), technologies, materials.
• Create and/or develop designs for potential new product solutions and/or improved product lines, and document the design and development.
• Performs mechanical and biomechanics testing
• Create complete models, drawings, specifications, and related documents required to produce products and prototypes.
• Follows established Best Known Methods and Standards
• Conduct design verification and validation activities.
• Maintain existing solutions through championing ECO's
• Provide leadership and mentorship to junior staff including interns
• Leads small teams
• Manage multiple tasks and smaller projects
• Create draft project plans and solicit 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
• Perform Design Control activities with some supervision
• Write clinical data reports
• Review and approve drawings in ECOs
• Support Regulatory with 510(k) and Technical File support documents
• Perform market analyses, work with Product Management on ROIs
• Interfaces with manufacturing, quality, planning, regulatory, and other departments on a regular basis to determine feasibility of new project ideas/concepts/designs.
• Act as independent reviewer on other projects
• Conduct patent analyses
• Performs complex mechanical / biomechanical analyses (ex: Finite Element Analysis, etc.)
• Create designs with significant complexity
• Develop presentations and present to external audiences
• Communicates effectively and forms relationships/collaborates with Surgeons/providers/consultants/Suppliers
• Develop/refine Acumed processes (SOPs, Work Instructions, etc.)

Qualifications

• Bachelors in Mechanical Engineering, Bio-Mechanical Engineering, or Equivalent
• 3-5yrs applicable experience and demonstrated ability to perform applicable job duties
• Competency in communicating anatomy/physiology (A/P)
• Proficient with application of GD&T
• Thorough understanding of anatomy
• Working knowledge of FDA and ISO requirements related to medical devices
The Packaging Engineer is responsible for packaging, product delivery and labelling solutions for medical devices from concept to commercialization. The Packaging Engineer works closely with Product Engineering, Product Management, Quality and Supply Chain teams to produce robust and cost-effective solutions that meet market and regulatory needs. Responsibilities include implementing new packaging, product delivery solutions, maintenance of existing packaging/ product delivery solutions/ labelling, testing and validation, and effective communication with team members, management and customers.

To apply, please visit our applicant registration page

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

Regulatory Affairs Manager Hillsboro, OR, USA Regulatory Nov. 18, 2014

General Duties/Responsibilities
• Establishes overall strategic plan for Regulatory Affairs, and manages the execution of all efforts targeted at fulfilling strategies.
• Participates in selection of suitable third party contractors, and interfaces with Regulatory affairs to ensure ongoing quality compliance.
• Manage maintenance of 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
• Oversee Preparation, organization, coordination of 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.)
• Develops and empowers people to focus on the customer.
• Creates a strong team environment based on and supporting company values.
• Articulates vision and strategy to executive management, peers and subordinates in order to gain quality systems compliance, commitments and results.
• Helps develop annual operating budget and manages activities to achieve expected ratios.
• Responsible for the review and performance of capital expenditures to ensure expected investment benefit is achieved.


Qualifications
• BA/BS in engineering or related field. (Masters preferred)
• Minimum of 5 years leadership/management experience in regulatory environment.
• Experience in medical device manufacturing preferred.
• Extensive knowledge of cGMP, FDP QSR CFR 820, MDR, ISO 9001, 9002, 13485, CE and other international standards.
• Proven problem-solving skills and the ability to train teams to resolve various issues using available tools.
• Extensive knowledge and experience in implementation of Six Sigma quality concepts and techniques.
• Familiarity with Lean Manufacturing concepts.
• Knowledge and experience with ERP/MRP systems and their applications.
• Exceptional organizational skills with extensive knowledge of MS Office (i.e. Excel, Word, Outlook)

To apply, please visit our applicant registration page

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

Senior Product Development Engineer Hillsboro, OR, USA Product Development Engineering Nov. 18, 2014

Job Purpose/Scope
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/or develop designs for potential new product solutions and/or improved product lines, and document the design and development
• Performs mechanical and biomechanics testing
• Participates in Cadaver Labs for internal product development
• Create complete models, drawings, specifications, and related documents required to produce products and prototypes
• Directs other staff on technical aspects across multiple projects
• May provide input to performance appraisals of lower level engineers
• Lead/mentor engineers, product designers, and other junior staff
• Provides input on direction and budgets for internal and external projects
• Leads multiple large cross functional engineering teams on critical projects
• Utilized for getting faltering teams back on track
• Develop potential IP concepts/designs and manage patent application process
• Interfaces with manufacturing, quality, planning, regulatory, and other departments on a regular basis to determine feasibility of new capabilities/concepts/designs
• Write high level documents (white papers, design rationales, technical answers etc.)
• Approve test protocols, test reports
• Creates and proliferates Best Known Methods / creates standards for design practices
• Serve as technical reviewer for business development opportunities
• Communicate effectively with executive team
• Organize and conduct cadaver labs with multiple surgeons
• Develop new surgeon relationships
• Forms relationships with new external partners/institutions both domestic and international
• Presents at External Forums/Conferences
• Defines and implements improvements to department processes
• Direct multiple projects and PDTs independently
• Approve design control documents, and Engineering Change Request (ECRs)
• Creates Standards/Policies/Infrastructure for Design Control activities
• Oversee and review important technical decisions for projects and lead root cause analysis activities, etc.

Qualifications
• Bachelors in Mechanical Engineering, Bio-Mechanical Engineering, or Equivalent with 6-12 years of related experience
• Ability to communicate independently and effectively with all levels of surgeons and demonstrated ability to develop new surgeon relationships
• Effective in organizing cadaver labs internally and externally with multiple surgeons and/or surgeon design team
• Ability to lead large complex projects
• Ability to independently develop solution and intellectual property
• Ability to independently create comprehensive and accurate design control documents
• Ability to effectively support 510k and Technical file submissions (assisted in 5+ products getting cleared/approved)
• Effective as an independent review for multiple projects
• Trusted resource for evaluation of business development opportunities (2+ evals)
• Advance knowledge of relevant surgical anatomy and techniques
• Independent Patent Analysis and ability to write technical product papers
• Expert reviewer of models, drawing and engineering standards
• Ability to investigate new product opportunities and make recommendations based on market/competitive analyses including ROI
• Ability to manage and/or mentor engineers, mechanical drafters and product designers
• Ability to communicate clearly and effectively with executive team and senior management

To apply, please visit our applicant registration page

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

International Regional Business Manager, Asia Pacific Hillsboro, OR, USA International Sales Nov. 24, 2014

Job Purpose/Scope
The International Regional Business Manager (IRBM) achieves sales goals through the recruitment, training, and motivation of a world class sales channel within an assigned region. The IRBM implements targeted sales strategies that align distributor sales goals with Acumed's strategic plan. Directs and oversees the distributor activities to ensure clear understanding of the sales goals and selling practices. Drives the selling process and supports sales activity for major accounts. Provides monthly metrics on progress to goals. The IRBM manages equipment and materials within assigned region in compliance with corporate policies and directives.

Duties/Responsibilities

• Devise and implement regional business strategies that drive sales to achieve revenue and market share growth rates.
• Create and continually re-evaluate competitive positioning to ensure market competitiveness and optimal sales strategy.
• Establish strategic relationships with key distributors to further penetrate the Acumed brand.
• Establish distributor goals and accountabilities, monitor progress and provide feedback on results.
• Devise and implement a sales plan and a yearly sales budget for area of responsibility.
• Monitor sales activities, report on results and sales activities on a weekly and monthly basis; Provide monthly and quarterly rolling forecasts.
• Partner with the Events team to plan and coordinate sales events that support the strategic plan.
• Partner with Product Management & Marketing/Communications to influence design, adoption and implementation of marketing programs that increase revenue and add value to the sales and customer support teams.
• Partner with Marketing/Communications & Business Services to ensure the sales channel has adequate collateral materials.
• Coordinate training of sales channel team members on the Acumed International sales cycle process and internal process for product ordering and product registration.
• Partner with Medical Education & Sales Training to ensure sales channel is properly trained and equipped with all required sales tools and surgical systems/products.
• Support new product launches and manage product mix for the region.
• Research competitors, gather information and analyze market data.
• Research and establish marketing pricing for the region.
• Research and analyze new local, regional, and national markets to identify market share growth opportunities.
• Perform financial analyses in support of special, expansion and investment pricing proposals.
• Ensure that distributor's activities and standard operating procedures regarding interaction with HCP (Health Care Professionals), product handling and complaints, expense reporting, sales activities and training meets all compliance and regulatory requirements.

Qualifications
• BA/BS in Business or related field required; Master's in Business Administration preferred.
• Minimum of five years of experience in sales channel management plus 3 or more years of experience as a sales representative; at least 2 years of International distributor experience with medical products or medical devices highly preferred.
• Must be highly organized, detail oriented and analytical to devise and implement a strategic plan.
• Ability to prioritize company objectives to meet sales goals.
• Ability to prioritize projects to meet aggressive deadlines.
• Must have proven track record of outstanding team leadership abilities and development of teams.
• Deep knowledge of business development principles related to strategic planning and resource allocation.
• Demonstrated track record of success in growing and managing international sales channels.
• Extraordinary strategy, communication, and presentation skills.
• Deep understanding of international markets and business practices.
• Ability to work collaboratively and independently in a cross-functional and team oriented environment.
• Outstanding interpersonal and relationship management skills.
• Multi language skills a plus.

To apply, please visit our applicant registration page

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