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Careers at Acumed

Looking for a career that makes a difference? Acumed provides a progressive and exciting workplace. Acumed's position as an innovator in the orthopaedic implant market means that we move quickly to take advantage of areas unaddressed by larger companies. This creates a dynamic environment in which employees are supported in growth and responsibility.

Our people are by far the most valuable resource we have. We believe strongly in empowering each other to make a difference in the future of the company and the lives of the patients who receive our implants.

Pushing the limits in orthopaedics takes us all to new heights, whether that’s in engineering, manufacturing, inspection, marketing, or compliance.

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

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Current Open Positions

Positionsort descending Location Department
Associate Product Manager Hillsboro, OR, USA Product Management

The Associate Product Manager (APM) provides primarily downstream support of Acumed's product portfolio. The APM is responsible for complex and varied tasks related to the introduction of new products to the global market and support of legacy products over the product lifecycle. Must remain abreast of industry trends and focus heavily on satisfying the customer. The Associate Product Manager is the first line of contact for most product-related inquiries. The APM also drives projects across many departments including Marketing, Sales, Product Management, and Product Development.

Duties/Responsibilities
• Collaborates with other departments to ensure timely and cost effective launch of products.
• Responsible for writing technical and promotional product information for marketing and communications to the field.
• Prepares product information documents, technical guides, and other marketing materials for assigned projects.
• Provides product information in response to customers' questions/requests, including sales data and survey results.
• Responsible for taking and answering technical calls regarding Acumed products, both during and outside of regular business hours.
• Represents Product Management team at Product Development Team meetings and is responsible for communicating and/or completing tasks assigned to Product Management.
• Assists in gathering voice of customer and market data by conducting surveys and recording customer feedback.
• Manages feedback from field regarding Acumed product and enters data into product feedback database and the Acumed complaint system.
• Facilitates use of secondary market research through purchased reports, market research vendor resources and other business development sources.
• Conducts primary market research based on published literature, consulting surgeon surveys and field surveys.
• Collaborates in creation of new product presentation materials. Secures visuals for use in product management presentations, training events and the creation of marketing materials.
• Conducts product training programs for internal and external customers.
• Provides product training to surgeons and sales partners at tradeshows, bioskills courses, cadaver labs and other product training events.
• Responsible for gaining general product knowledge of the entire Acumed product portfolio in order to independently represent Acumed at events.
• Assists in developing surgeon relationships for consulting, product development, case studies, etc.
• Supports and participates in continuous improvement activities.

Qualifications
• BA/BS degree in Marketing or related field of study highly preferred.
• 2+ years of work experience in marketing or related field.
• High level verbal and written communication skills required for interacting with customers and coworkers.
• Must demonstrate strong presentation skills and the ability to create and deliver presentations to large groups of peers and customers.
• Proven positive and professional demeanor.
• Self-starter; ability to take ownership over processes.
• Advanced computer skills working with Excel and PowerPoint, proficient in remaining MS Office Suite.

To apply, please visit our applicant registration page

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

Business Services Specialist Hillsboro, OR, USA Business Services

The Business Services Specialist interacts with customers to provide information in response to inquiries, receive orders for products, and works to handle and resolve complaints following established procedures to ensure that good customer relations are maintained, and complaints are resolved fairly and effectively, and in accordance with Acumed procedures. He or she will accurately and efficiently process orders, maintain reports, initiate process improvements, and provide effective communication. Assists senior staff on order status, product information, account status, pricing, product or service.

Duties/Responsibilities
• Confer with customers by telephone and email to provide information about products or services, take or enter orders, or obtain details or complaints
• Ensure that issues are resolved both promptly and accurately
• Assist with resolving billing issues and shipping discrepancies
• Gather documentation and complete required forms for resolution
• Efficiently and accurately enter customer orders
• Receive and record customer complaints professionally and accurately, refer unresolved complaints to designated departments for investigation
• Work with Planning, Logistics and other departments to ensure best results for customers

Qualifications
• High School diploma required; Associates or Bachelor's degree preferred plus minimum of 1-2 years customer service experience required
• Excellent people skills and 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
• Strong working knowledge of MS Office (Word, Excel, Outlook)

To apply, please visit our applicant registration page

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

Business Services Specialist Hillsboro, OR, USA Business Services

The Business Services Specialist interacts with customers to provide information in response to inquiries, receive orders for products, and works to handle and resolve complaints following established procedures to ensure that good customer relations are maintained, and complaints are resolved fairly and effectively, and in accordance with Acumed procedures. He or she will accurately and efficiently process orders, maintain reports, initiate process improvements, and provide effective communication. Assists senior staff on order status, product information, account status, pricing, product or service.

Duties/Responsibilities
• Confer with customers by telephone and email to provide information about products or services, take or enter orders, or obtain details or complaints
• Ensure that issues are resolved both promptly and accurately
• Assist with resolving billing issues and shipping discrepancies
• Gather documentation and complete required forms for resolution
• Efficiently and accurately enter customer orders
• Receive and record customer complaints professionally and accurately, refer unresolved complaints to designated departments for investigation
• Work with Planning, Logistics and other departments to ensure best results for customers

Qualifications
• High School diploma required; Associates or Bachelor's degree preferred plus minimum of 1-2 years customer service experience required
• Excellent people skills and 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
• Strong working knowledge of MS Office (Word, Excel, Outlook)

To apply, please visit our applicant registration page

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

Cadaver Lab Coordinator Hillsboro, OR, USA Medical Education

Job Purpose/Scope

 Under general supervision, the Cadaver Lab Coordinator (CLC) follows established procedures to perform the routine tasks to maintain the Acumed Learning Center (ALC) cadaveric training facility. He or she maintains the ALC calendaring, inventory management, proper handling of cadaveric specimens, training staff on lab safety, and onsite coordination of training courses, product development labs, and other ALC uses.

Duties/Responsibilities

  • Coordinates lab related aspects of onsite cadaveric courses including managing and ordering required tools, hardware, and tissue specimens, lab setup, restaging tables and post-course clean up.
  • Manages cadaveric specimens used in the ALC including: ordering, preparation, inventorying, and returning them to the supplier.
  • Coordinates staff planning for assigned courses.
  • Ensures training center equipment receives regular preventative maintenance.
  • Provides staff and course attendees with bloodborne pathogen and lab safety training.
  • Monitors ALC cadaveric courses ensuring all participants adhere to proper safety and personal protective equipment protocols.
  • Ensures ALC and associated cadaveric tools and equipment are properly cleaned and sterilized according to OHSA standards.
  • Cleans and sterilizes Acumed product trays used for cadaver trainings on and offsite in preparation for restocking with marketing materials.
  • Assists in course scheduling, material ordering, catering, hotels, transportation, badge creation, certifications, attendee logs, waiver form collection, transparency reporting and other arrangements as necessary for onsite cadaveric trainings.
  • Manages inventory for ALC instruments, personal protective gear, and lab supplies.
  • Reviews and provides recommendations and modifications which improve quality, costs and vendor selection.
  • Adheres to medical education budget.
  • Provides clerical and administrative support to the Medical Education and Product Training team as needed by assisting with catering orders, arranging shuttles, creating POs, booking hotel rooms, and providing registration support.

  Qualifications

  • High School Diploma or equivalent required/.
  • Proficiency in MS Office programs including Word, Excel, and Outlook.
  • Strong verbal and written communication skills required for interacting with customers and coworkers.
  • Demonstrated ability to efficiently manage time and multi-task.
  • Superior organizational skills and attention to detail.

To apply, please visit our applicant registration page

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

CNC Machinist (swing shift) Hillsboro, OR, USA Production

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

Work Location: Cornelius Pass Screw                                                                                                                                   

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 2-4 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.

CNC Machinist II (swing shift) Hillsboro, OR, USA Production

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: Brookwood

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.

Director, Information Technology Hillsboro, OR, USA Information Technology

Job Purpose/Scope

The Information Technology (IT) Director develops, manages and maintains all internal information systems and enterprise architecture utilized by Acumed employees. He/She creates a long term roadmap to create and maintain systems and infrastructure, alerting the Executive Team to enterprise architecture needs and costs with sufficient lead time to establish budgeting to fund future needs. The IT Director maintains a project tracking process that establishes funding and timelines for IT projects, and monitors performance against those targets. He/She recommends the priority of IT projects to the CFO and Executive Team, and adjusts project priorities and timelines according to the needs of the organization. He/She hires, trains, and directs the daily efforts of a professional workforce.

Duties/Responsibilities

  • Leads strategic technological planning to achieve business goals by prioritizing technology initiatives to enhance the enterprise architecture and coordinating the evaluation, deployment, and management of current and future technologies.
  • Develops business case justifications and cost/benefit analyses for technology spending and initiatives.
  • Collaborates with the appropriate departments and outside vendors to develop and maintain a technology plan that supports organizational needs.
  • Directs development and execution of a disaster recovery and business contingency plan.
  • Analyzes complex business needs presented by Acumed's user community and recommends technical solutions to the Executive Team.
  • Ensures adequate IT resources and support are provided for all Acumed buildings, remote users (including international travelers and employees), and subsidiaries.
  • Provides technical support in addressing building and equipment maintenance services, along with other services necessary for buildings and business operations.
  • Defines and communicates corporate procedures, policies, and standards for the organization for acquiring, implementing, and operating new network systems, equipment, software, and other technologies.
  • Contributes collaboratively within a fast-paced environment to ensure design and delivery of high quality solutions which adhere to industry standards for architecture, security and privacy, and best practices.
  • Conducts research to remain up-to-date and knowledgeable in regards to industry trends and emerging technologies in anticipation of new business processes and system alterations.
  • Stays abreast of technological trends; ensures that the company is making the best use of available technology.
  • Ensures maximum uptime of all information systems impacting company business including SAP system, desktop computers and associated software, business machines, cell and smart phones, and telephone systems.
  • Analyzes and improves upon technology standards across the organization to maintain a technological and competitive edge within the market.
  • Directs and prioritizes the workload of subordinate personnel and assists with workload prioritization as needed.
  • Ensures continuous delivery of technical services through oversight of service level agreements with end users and monitoring of systems, programs, and equipment performance.
  • Conducts and coordinates analysis, design and implementation of computer based information systems to meet user requirements.
  • Performs performance and conducts interviews and makes recommendations for new hires, consultants and/or replacement personnel.

 Qualifications

  • Bachelor's degree in Computer Science or related field. Master's degree preferred
  • 8 - 10 years of experience managing or directing technological operations with a proven ability to lead a progressive IT team to develop and implement IT program in a business environment
  • Prior supervisory experience required
  • Strong hands-on knowledge of technology environments, including telecommunications, networks, security, programming, server administration, and Helpdesk operations
  • Ability to work with multiple technologies, aptitude for new technologies and ability to effectively apply technological solutions to business problems
  • Proven experience in planning, organization, implementation and development
  • Experience successfully managing the support of SAP or another tier one ERP system
  • Ability to provide strong leadership and timely/effective performance feedback
  • Excellent written and oral communications, with ability to articulate ideas to both technical and non-technical addressees
  • Exceptional organizational skills; proven ability to multi-task
  • Able to maintain the confidentiality of sensitive information

To apply, please visit our applicant registration page

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

Global Surgeon Relations Manager Hillsboro, OR, USA Product Management
Duties/Responsibilities
  • Provide input in selection of faculty for clinical studies and Acumed Bioskills training events.
  • Work in collaboration with Medical Education leadership to implement strategies to engage thought leaders at academic institutions.
  • Provide support in organizing Key Opinion Leaders for participation in surgeon training, product validation and product evaluation labs.
  • Gather, compiles and analyzes clinical feedback from key thought leaders to provide recommendations and market delivery strategies to Engineering/ Product Management throughout the Acumed Product Life Cycle.
  • Collaborate with product management and field sales to develop KOL profiles and geographically maps and assesses KOL impact in local, regional, national and global markets.
  • Use research and assessment data to evaluate universities, clinics, research foundations and other related centers of excellence for use in identifying key thought leaders in relevant educational and clinical roles.
  • Partner with Compliance to regularly audit surgeon hourly algorithm.
  • Collaborate with Product Development and Compliance to ensure proper royalty contracts are communicated to surgeons.
  • Create training program for Acumed in house personal on proper HCP interactions.
  • Collaborate with Compliance to continually update to keep current the Acumed Consultant Contracts, Travel Policy standards and medical education payment provisions.
  • As a key contact, cultivate and maintain global key opinion leader relationships.
  • Develop key thought leader engagement strategy and collaborates cross functionally to execute on tactics.
  • Develop and train direct reports to ensure appropriate skills/behaviors are present to achieve strategic objectives. Set and monitor strategic goals; perform annual performance appraisals for direct reports.
  • Maintains 100% compliance with Acumed policies, AdvaMed codes and all applicable laws and regulations.
Qualifications
  • Bachelor's Degree in Business, Healthcare or Public Health Administration plus minimum 8 years' experience in orthopedic implant sales or equivalent combination of education and experience.
  • Strong understanding of healthcare environment and orthopedic medical device industry.
  • Demonstrated knowledge and understanding of regulatory and compliance requirements related to medical device industry and Advamed provisions specific to HCP engagement and interaction.
  • Ability to apply research and assessment data in developing plans, tactics and implementation processes.
  • Ability to communicate in a clear, concise, and professional manner, tailored to the appropriate audience; including both verbal and written communications.
  • Professional image, highly articulate, goal-oriented, with high integrity and strong ethics.
  • Creative, innovative thinker with strong strategic mindset and understanding of market needs.
  • Proven track record of strong team work, innovation, and project management.

To apply, please visit our applicant registration page

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

Medical Education Program Manager Hillsboro, OR, USA Medical Education

The Medical Education Program Manager (MEPM) is responsible for developing and hosting medical education courses. This MEPM works with surgeon subject matter experts to develop and oversee course objectives, curriculum, educational tools, presentations, and hands-on workshops. The MEPM designs educational courses based on clearly defined objectives which meet the needs of the surgeon attendees. Work includes implementing platforms and event coordination for group instruction, lectures, demonstrations and workshops to provide high quality surgeon education programs under the supervision of the Director of Medical Education and Product Training.

Duties/Responsibilities
• Partner with subject matter experts to document complex medical education materials, handouts, lesson plans and multimedia presentation materials.
• Assist in the development and maintenance of educational curriculum, including multi-media educational learning objects.
• Adapt pre-designed course materials to meet instructional objectives.
• Ensure all prepared materials are based on clearly defined regulatory, compliance and internal policies and guidelines.
• Implement comprehensive training structure for HCP's including: surgical staff, residents, Fellows and champion surgeons.
• Review and continuously improve upon existing instructional materials, course agendas, lecture topics, lesson plans, handouts or demonstrations.
• Collaborate with internal partner teams (i.e., Product Management, Marketing, Sales) to plan and implement surgeon educational programs on the international, national, and regional level
• Assist in organizing onsite and offsite workshops and educational courses for surgeons, business partners and other work groups as assigned.
• Coordinate registration, hotel arrangements, catering, transportation, course evaluations and documentation with internal and external partners.
• Document surgeon expenses related to educational courses.
• Generate surgeon invitations, statements of work (SOW), engagement expectations, document activities, and ensure fee-for–service and reimbursement payments relevant to the program.

Qualifications
• Bachelors Degree in Science, Communications, Education or related field
• 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, verbal 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.

To apply, please visit our applicant registration page

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

Network Engineer Hillsboro, OR, USA IT

The network engineer is responsible for the capacity planning, improvement and maintenance of Acumed's network infrastructure and related components. This is an exciting opportunity for a motivated Network Engineer looking for high-visibility role on a talented IT team!

Duties/Responsibilities
• Provide functional and empirical analysis related to the planning, evaluation, design, installation, and implementation of all network infrastructure components.
• Maintain seamless network operation and provide maximum uptime.
• Support acquisitions of network hardware and software.
• Perform maintenance of network devices. Backup configurations and perform hardware restorations as necessary.
• Ensure network security using IPS/IDS, Network Monitoring, Port Security, Auditing and Firewall Analysis, Access Control Servers (Radius/Tacacs)
• Work with end-users, support team members & contractors to resolve network issues.
• Negotiate and maintain relevant contracts with outside services and suppliers.
• Maintain telecommunications circuits and related hardware.
• Engage IT staff and users in order to be proactive and work collaboratively on IT Projects when needed.
• Backup to PC Support Technicians and Systems Engineer as needed.

Qualifications
• Minimum 4-year degree or equivalent experience in Computer Science or related field.
• Two plus years of related network infrastructure experience.
• Exceptional written and verbal communication.
• Strong time management skills, including the ability to multi-task.
• Work well independently and in a team environment.
• CCNA Routing and Switching/CCNA Security or similar level of knowledge preferred
Specific Applications – experience and knowledge of some or all of the following is preferred:
• Working experience of network protocols (including TCP/IP, UDP, NetBIOS, SNMP, SMTP, DHCP, WINS, DNS, Radius, Tacacs, FTP, SSH) and operating systems such as Cisco IOS, ASA, ACS, WLC, Windows Client Servers environment.
• Working experience in selecting, maintaining and implementing network components such as routers, switches,
• network monitoring appliances, VPN's, Zone Based Firewalls, Packet Filtering, Wireless Controllers and Access Points, DMZ and VOIP.
• Working experience with various Routing protocols in redundant and highly available environment EIGRP required; OSPF and BGP a plus
• Working experience with L2 – L3 Switches in a hierarchical network (including VLAN, stacks, Spanning Tree Protocol, L2 security, Access Lists implementation, basic QoS)
• Working Experience with Windows Networking that includes Exchange, Domain Servers, AD Structure, etc.
• Working Experience with some or all of the following network tools and management software such as, Wireshark, Netflows, Google Postini, Cisco ASDM, Cisco CLI, Cisco Network Assistant, Microsoft Visio (or similar design tool)
• Through understanding of the Network ISO/OSI Model.
• Knowledge of various cables and links
• Knowledge of Hardware Network Load Balancers a plus
• Knowledge and experience with Network Monitoring System such as Solarwinds Orion NPM, NTA, Google Apps for business a plus
• Preferred experience with Enterprise Cisco Equipment (including Catalyst series, Nexus, ASA Firewalls, ACS) and Dell Force 10 switches

To apply, please visit our applicant registration page

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

Process Engineer III Hillsboro, OR, USA Process Engineering

The Process Engineer (PE) supports 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 manufacturing process instructions and documentation
• 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
• Develop and implement advanced inspection methods and gaging
• Manage and approve corrective/preventative actions (CAR/SCAR)
• Evaluate inspection frequency considering risk management and process capability
• Implement Statistical Process Control (SPC) methods and tools – use to determine root cause of failures and make recommendations in process changes.
• Lead system level Process Improvement (PI) initiatives & implement Lean tools
• Manage all manufacturing details of new product launches
• Review and Approve Process Validation protocols and reports
• Prepare new equipment proposals including ROI justification
• Lead cross-functional groups
• Communicate effectively with management
• Manage multiple projects with limited supervision

Qualifications
• B.S. Degree in Engineering (Mechanical, Manufacturing, Industrial) or equivalent
• 5+ years process engineering or related experience
• Advanced 3D CAD experience in Autodesk Inventor, Solidworks, PRO-E or equivalent
• Applied understanding of Geometric Dimensioning & Tolerancing (GD&T)
• Applied experience with of Process Validation (IQ, OQ, & PQ) requirements
• Applied experience with statistical tools such as control charts, trending, and capability

To apply, please visit our applicant registration page

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

Quality Engineer II Hillsboro, OR, USA Quality

The Quality Engineer II serves as a resource to product development and manufacturing to improve product quality, reliability, and process capability and participate on teams in identifying, documenting, assessing, correcting and presenting quality issues using risk analysis and root cause analysis tools. Under general supervision, responsible for quality planning & 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).

Duties/Responsibilities
• Provide quality representation to design control, design verification and validation, design transfer, process validation, risk management, and specification development on assigned product development teams to assure compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485.
• Participate on teams to ensure robust application of appropriate design and manufacturing controls. .
• Under supervision, advise project teams on compliance related to regulations, procedures, and requirements. Provide training, guidance and interpretation.
• Work with senior engineers and leadership to 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.
• Under close supervision, enhance and drive product risk management activities. Ensure identified activities and mitigations are executed as agreed.
• Participate in technical discussions and risk-based decision making.
• Under supervision, review 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.
• Identify opportunities and recommend improvements to design and development process; continuous improvement.
• Report status updates on assigned responsibilities and goals; timely escalation of issues

Qualifications
• Bachelor's degree in an engineering or science discipline
• 3-5 years of experience working in quality assurance role in a regulated environment
• Experience working with implantable devices preferred
• Experience applying quality regulations and standards preferred (e.g. 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.)
• Experience with CAPA and failure investigation tools and techniques.
• Practical experience with quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.)
• Ability to identify problems, review related information, develop and evaluate options, and implement solutions
• Skilled oral and written communicator
• Proven track record of success in teamwork
• Ability to be flexible in a dynamic work environment with shifting priorities.
• Knowledge of ERP Systems (SAP preferred) and intermediate Microsoft Office; intermediate/advanced level Microsoft Excel 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

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.

Acumed is an equal opportunity employer. All qualified applicants will receive consideration for employ ment 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 a disability.

As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at recruiting@acumed.net.

EEO is the Law Poster
Acumed EEO Policy Statement
Acumed participates in E-Verify. Details in English and Spanish.
Right to Work Statement in English and Spanish.