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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
Quality Manager, Acute Innovations Hillsboro, OR, USA Acute Mar. 05, 2015

The Quality Manager for Acute Innovations is responsible for directing Quality Assurance activities to support all aspects of Quality programs. They build successful teams, develop and lead people to achieve continuous improvement and drive change throughout the organization.

Acute Innovations is a subsidiary of Acumed.

Duties/Responsibilities
-Management representative for the quality system, which maintains compliance to FDA/QSR requirements.
-Oversee quality and inspection operations.
-Coordinate the inspection and quality duties throughout company.
-Assure ongoing compliance to the Quality Assurance Manual.
-Support and participate in the quality objectives within the company.
-Supervise Quality personnel.
-Qualifies and monitors vendors.
-Reviews, approves, verifies, and participates in Corrective Action.

Qualifications/Requirements
-B.S. in Engineering or related field
-Thorough knowledge and experience in FDA, CMDCAS, ISO, and MDD
requirements and consensus standards.
-5+ years of quality assurance experience preferred
-Experience in the medical device or equivalent industry (quality or
medical device engineering)

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 Apr. 08, 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.
• Orthopaedic, trauma, dental, or spine experience 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.

Instructional Designer Hillsboro, OR, USA Medical Education Apr. 10, 2015

The Instructional Designer develops and designs curriculum and content for Medical Education and Sales Training programs for Acumed personnel and customers to promote the safe use of our products, increase product knowledge, and sales techniques. This position combines in-depth knowledge of adult learning theory and skill development, various forms of instructional media, and facilitation expertise. The Instructional Designer develops an entire curriculum from individual courses to entire programs, with multiple coursework. Keeps abreast of emerging instructional design theory, instructional technologies, and developments in technology enhanced learning tools by participating in professional development and research activities.

Duties/Responsibilities
• Develop training objectives roadmap for overall curriculum structures and develop education plans for each project. Design and implement the process for curriculum planning and course development.
• Develop project proposals including budgets, timelines as part of curriculum development process.
• Design, develop and implement e-learning and classroom training for various target audiences using appropriate writing styles to make content easy to understand. 
• Create online self-paced training modules that reinforce key anatomy, procedure, and product objectives.
• Analyze learning aims and objectives and work with Subject Matter Experts (SMEs) to design solutions that align with learner and business needs. Apply instructional design theories and practice.
• Develop training on competitive product initiatives to ensure field salesforce can respond to competitive product offerings.

Qualifications
• Bachelor's degree in Education, Clinical (R.N. RPh) or Technical area such as engineering or science required. MS in Instructional Design & Development or Education preferred
• 3 or more years of experience developing educational content at the corporate level
• Prior curriculum design experience required; Instructional Design & Development or Education preferred.

To apply, please visit our applicant registration page

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

Process Engineer Hillsboro, OR, USA Process Engineering Apr. 22, 2015

The Process Engineer (PE) supports Wet Processing production cells and new product development teams to meet operational objectives by developing, integrating, and improving production processes and systems. The Process Engineer also ensures compliance to Acumed, FDA, and ISO regulations.

Duties/Responsibilities
• Develop and implement advanced production fixtures
• Develop new production Routes, Bill of Materials (BOMs), and Inspection Plans via ECOs
• Manage Quality Notification (QN) system and disposition all non-conforming product
• Support corrective/preventative action activities (CAR/SCAR)
• Prepare and analyze quality metrics to identify repeated quality issues
• Lead cell level Process Improvement (PI) initiatives and implement Lean tools
• Develop manufacturing plans and timelines for new product release
• Review new product design for manufacturability prior to production release
• Coordinate Pilot Production Runs and conduct production readiness reviews (PRR)
• Develop and execute Process Validation protocols and reports
• Implement and improve upon existing manufacturing processes

Qualifications
• 2-6 years process engineering or related experience
• Applied 3D CAD experience in Autodesk Inventor, Solidworks, PRO-E or equivalent
• Applied understanding of Geometric Dimensioning & Tolerancing (GD&T)
• Applied understanding of Process Validation (IQ, OQ, & PQ) requirements
• Wet Processing experience desired
• Experience in the Medical Device industry desired
• Knowledge of FDA and ISO 13485 Regulations
• Understanding of Risk Management and experience with tools such as FMEA

To apply, please visit our applicant registration page

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

Quality Assurance Technician Hillsboro, OR, USA Production Jun. 23, 2015

The Quality Assurance Technician inspects material, products, or processes, purchased or manufactured, to the required drawing or print specification, or other controlling document.

This position is assigned to a mid-day shift.


Duties/Responsibilities
• Perform first article dimensional and documentation inspections.
• Audit In-process records, receiving inspection documentation, final inspection documentation, and other quality or manufacturing data for accuracy and completeness.
• Evaluate inspection processes for improvement using standard problem solving and improvement techniques (i.e. Redundant inspections, improved techniques and instructions).
• Actively participate in Manufacturing Cell teams as a Quality representative by addressing quality-related issues per documented processes.
• Accurately enter information into manufacturing data gathering system.
• Maintain and update Quality system documentation, such as work instructions, procedures, in-process inspection information, and other related documentation.
• Address and follow-up on quality-related issues between departments (i.e. Manufacturing Engineers, Design, Quality Engineers, Planning, Manufacturing).
• Demonstrate an understanding of final acceptance activities.
• Create Non-Conforming Material Reports (NCMR's) as needed.
• Participate in MRB (Dispositions – NCMR).
• Maintain calibration of gages and integrity of calibration system by accurately entering information.
• Track the status of receiving inspections (FIFO, Visual Indicators).


Qualifications
• High School Diploma/GED or equivalent
• Two years manufacturing experience required; 1 or more years of experience in manufacturing inspection preferred.
• Ability to read and speak English sufficiently to read work instructions, specifications and procedures and complete all paperwork.
• Ability to use precision measuring equipment including micrometers, calipers, gage pins, optical comparators, and other inspection equipment.
• Ability to read and understand engineering drawings and specifications related to manufactured products.

To apply, please visit our applicant registration page

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

Senior Graphic Designer Hillsboro, OR, USA MarCom Jun. 26, 2015

The Senior Graphic Designer combines graphic design and marketing to create marketing materials that represent the Acumed brand. The Senior Graphic Designer leads the design process and participates in strategy development for promotional materials to support events, trainings, product launches and corporate promotional campaigns.


Duties/Responsibilities
• Designs complex or difficult projects using expertise and knowledge to graphic design principles.
• Serves as the lead designer to turn visualizations into comprehensive designs that extend brand messaging across multiple media channels to deliver effective marketing materials within budget guidelines.
• Maintain and promote the Acumed Global Brand/Identity Guide.
• Manage project workload for quality and adherence to deadlines. 
• Work with US and International Marketing Managers to understand market segments and develop marketing promotions to target them.
• Collaborates effectively to evaluate, identify and recommend opportunities to strengthen the Acumed brand and amplify customer brand experience.
• Develops and produces creative brand designs to ensure imagery and messaging promotes Acumed's brand identity.

Qualifications
• BS/BA in Graphic Design or related field required 
• 4 years or more experience in graphic design
• Manage multiple priorities, be detailed focused, and highly organized

To apply, please visit our applicant registration page

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

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.

Quality Systems Specialist Hillsboro, OR, USA Quality Jul. 16, 2015

The Quality Systems Specialist (QSS) uses independent judgment to design, implement, and manage the Corrective and Preventive Action Program (CAPA), the Internal Quality Audit System, and Field Actions Program related to implicated product.  The QSS implements and maintains the Acumed quality system in compliance with applicable regulations.  Research and implement current regulations to ensure multiple interdependent systems (CAPA, Quality Audit, and Field Actions Program) are updated and compliant with current requirements.  The QSS drives integration of various quality systems to ensure continuous compliance with global quality system requirements and ensures the processes supporting the quality system are robust and support the evolving requirements of Acumed's product line.

Duties/Responsibilities
• Owns and executes all aspects of CAPA program administration ensuring compliance with the quality standard. CAPA program administration includes authoring, updating, and driving compliance with standard operating procedures (SOPs), work instructions (WIs), and forms. 
• Respond to CAPA requests and open new CAPAs when appropriate.
• Verify CAPAs are thoroughly investigated and accurately documented in the system.
• Review all CAPAs prior to closure to assure all required actions were completed; perform effectiveness checks at established intervals in a timely manner.
• Partner with senior leadership to ensure CAPAs are appropriately resourced for closure within a reasonable timeframe.
• Own and execute all aspects of Acumed's Internal Quality Audit system administration ensuring compliance with the quality standard. Internal Audit system administration includes authoring, updating, and driving compliance with standard operating procedures (SOPs), work instructions (WIs), and forms. 
• In collaboration with the Quality Manager, create, distribute, and maintain the annual internal audit schedule.
• Coordinate with leaders in other departments to ensure sufficient auditing resources are available to support the audit schedule.
• Mentor and develop Acumed employees in other departments as internal auditors; coordinate required external certification to qualify internal auditors.
• Ensure audits are completed on schedule, results are communicated to the appropriate people, and the internal audit findings are promptly closed by collaboration with responsible department leaders.
• Support the Quality Manager during third party (i.e. Notified Body, FDA, Health Canada, ANVISA) assessments of Acumed's quality system.
• Assess, report, and implement new and changing regulations or the addition of new markets to the quality system.
• Execute Field Action activities by coordinating and facilitating the removal of implicated product from the field.
• Manage the creation and approval of Health Hazard Evaluations (HHEs) ensuring input and agreement from stakeholders
• Analyze HHEs in preparation for management review.
• Create, maintain, and disseminate reports and metrics on CAPA system activities, Internal Quality Audit system, and Field Actions for management.


Qualifications
• Bachelor's degree in an engineering or science discipline required; advanced degree preferred
• 5-10 years of experience in a quality role in medical device manufacturing.
• Working knowledge of applicable Code of Federal Regulations and ISO 13485.
• Extensive knowledge of Quality System Regulation, US FDA, and ISO 13485. Experience with international quality system regulations preferred.

 

To apply, please visit our applicant registration page

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

Packager Hillsboro, OR, USA Special Processes Jul. 20, 2015

The Packager performs manual packaging operations or sets up and operates machinery to pack and/or wrap containers with finished product for storage or shipment.

This is a great opportunity with a growing manufacturing department. This position is eligible for a robust medical benefits package, annual discretionary bonus opportunity, 401(k) plan, and much more!


Duties/Responsibilities
• Package all non-sterile product for storage in inventory
• Identify product according to label and insert appropriate documentation
• Consistently and accurately inspect, verify, and reconcile orders and labels
• Observe operations and inspect packaged items for conformance with specifications
• Identify equipment malfunctions and report needed repairs
• Maintain accurate inventory of packaging materials


Qualifications
• High school diploma or equivalent combination of education and experience
• Ability to communicate effectively with coworkers and supervisor
• Ability to read and speak English sufficiently to read, understand and complete all paperwork.

To apply, please visit our applicant registration page

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

Regulatory Affairs Specialist I Hillsboro, OR, USA Regulatory Jul. 28, 2015

The Regulatory Specialist I helps create, develop and maintain materials needed for regulatory compliance. Assists with company compliance activities, new product submissions, listings, and registration of medical devices. This is a great opportunity for a junior Regulatory Affairs professional!

Duties/Responsibilities
• Understands regulations, follows complex directions, and investigates when clarification is needed.
• Initiates International product registration, including renewals or changes and certificates for foreign governments
• Manages correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, Medimark
• Prepares, organizes, and coordinates data for submission to the FDA or regulatory agencies (e.g. 510(k), MDD Technical Files, etc.)
• Participates in the preparation and execution of ISO and FDA audits
• Assures regulatory compliance and content accuracy of Technical Files and 510(k) files
• Completes the duties described in the Quality Manual
• Converts and/or approves ECRs/ECOs requiring regulatory review
• Assists in package insert (instructions for use) development, organization and application
• Assists in determination of appropriate safety, regulatory, evaluation and testing requirements for new and approved products
• Product development design review team and risk team contributor, providing regulatory/compliance perspective and expertise, to assure products are in compliance with relevant US and foreign standards, codes and regulations


Qualifications
• Bachelor of Science in Biology, Chemistry or related field required
• Knowledge of applicable FDA, CMDCAS, ISO, and MDD requirements and consensus standards
• 1 - 3+ years of regulatory experience
• Ability to support product development projects

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 Jul. 28, 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.

US Shipping Specialist Hillsboro, OR, USA Logistics Aug. 05, 2015

The US Shipping Specialist follows established procedures to ensure US shipments and associated priorities are completed daily while supporting International Shipping activities when assigned. This entry-level logistics opportunity offers a robust benefits package, paid time off, competitive pay, and consistent work hours!


General Duties/Responsibilities
• Generate, pull, package and label deliveries for outbound shipments and perform inventory movements within the warehouse.
• Inventory movements (replenishments, returns, and incoming finished goods).
• Analyze shipping volumes; open customer orders and priorities to ensure on time delivery.
• Interact with Business Services representatives and other customers, couriers and freight forwarders to ensure all shipments are completed in a timely matter. 
• May assist with training.
• Perform inventory audits when necessary; document and reconcile internal and external errors as reported.
• Understand all department metrics to support and participate in process improvements.
• Support International Shipping activities. May assist with picking/assembly of consignment and launch sets.

Qualifications
• High school Diploma or GED.
• Warehouse/shipping experience preferred.
• Ability to produce results, prioritize tasks and manage time effectively, set a good example for others, project a positive, professional demeanor at all times.
• Highly detail-oriented and self-motivated with good organization skills and habits.
• Computer literacy required and experience with MS Office suite preferred (Word, Excel, Outlook).

To apply, please visit our applicant registration page

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

CNC Machinist Hillsboro, OR, USA Production Aug. 19, 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 entry-level 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

Duties/Responsibilities

•Uses established practices to ensure Quality during operation including documentation and techniques.
•Monitors machine performance.
•Performs preventative maintenance as required.
•Performs general set-ups to ensure maximum utilization.
•Troubleshoot problems under the guidance of Senior Machinists.
•Work with Process Engineers to improve Cell processes.

Qualifications

•Generally requires 0-2 years CNC equipment operating experience.
•Ability to operate machine tools safely and understand set-up instructions.
•Familiar with basic blueprint reading or ability to acquire blueprint reading skills.
•Familiar with basic Inspection techniques and processes, or ability to learn and understand them.
•High School diploma or equivalent

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 Aug. 28, 2015

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.