Design Transfer Engineer

Job description

• Primary driver for the quality and compliance aspects of Design transfer and on-market change management.


• Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of the client.


• Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.


• Own change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor to ensure timely closure.


• Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.


• Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.


• Assist 3rd party suppliers during change management process, including change management strategies.


• Identify gaps in existing processes as well as the need for new processes.
  
  Lead cross-functional teams for solution development and implementation.


• Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.


• Participate in the development of global Product Quality Assurance strategy to support device and combination products produced at the client s plants as well as contract manufacturing and supplier facilities.
  
  Implements agreed strategy.


• Make recommendations for key decisions on product quality, compliance and regulatory conformance issues.


• Establish and maintain relationships and open communication with suppliers, contract manufacturers, the client s plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.


• Initiate assignments independently.
  
  Actively lead and participate on development and process improvement teams.
  
  Anticipate/resolve quality issues and take preventative actions.


• Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements.
  
  Write/review policies/processes/procedures and related documents.


• Conduct, lead, or participate in investigations and review boards for Change Plans, CAPAs, NCRs, Observations, etc.

• Bachelor s degree in Science, Engineering, or other technical areas; or equivalent job experience required.
  
  Advanced degree preferred; ASQ certification preferred (CQA, CQE, SSBB, etc.)


• 8+ years of relevant experience in the medical device industry; at least 5+ years in Quality Assurance experience required.


• Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR).


• Working knowledge of international standards and regulations applicable to medical devices and combination products.


• Experience with medical devices and/or combination products such as infusion pumps, PFS, Autoinjector, or Eyecare Products preferred.


• Ability to apply practical and technical problem solving to quality system and product improvements.


• Excellent interpersonal skills, including ability to work effectively cross-culturally and cross-functionally.


• Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist.


• Capable of developing matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives.


• Champions high quality deliverables, innovation, and appropriate risk-based decision making; Ability to understand the sensitivities within the client s environment.


• Excellent project management and interpersonal skills.


• Adaptable to changes in work environment.


• Ability to work in a fast-paced environment.

• 401(k)


• Medical, Dental and Vision Insurance


• Term Life Insurance


• Accidental Death and Dismemberment


• Long Term Disability

Required Skill Profession

Other General