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Principal Quality Engineer
2 months ago
We are seeking a highly skilled Principal Quality Engineer to join our team at Medtronic. As a key member of our Advanced Surgical Technologies organization, you will be responsible for providing risk management expertise and best practices for released products and post-market activities.
Key Responsibilities- Evaluate product issues to ensure patient, user, and security risks are assessed.
- Act as the lead Design Quality Engineer for post-market design changes on capital hardware and disposable products.
- Provide comprehensive support to Post Market Development Teams with a focus on Design Quality and Risk Management.
- Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post-market life-cycle phase.
- Conduct health hazard assessments for fielded products, Corrections & Removals assessments, and collaborate cross-functionally to perform bounding/scoping for field actions.
- Assess risks that were not previously identified, as well as potential risks associated with changes in therapy, systems, products, components, manufacturing processes, and more.
- Bachelor's degree required.
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.
- Excellent communication and technical writing skills.
- Experience in Manufacturing and/or Electro-Mechanical Medical Devices.
- Leadership-level domain expertise in a technology discipline within Engineering, Research & Development, or Sustaining existing technology/products.
- Six-Sigma greenbelt or blackbelt certification.
- Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC).
- Understanding of Risk Management in accordance with ISO 14971.
- General understanding of Design controls in accordance with ISO 13485.
- General understanding of GMP/GDP.
- Familiarity with Supplier Qualification activities.
- Experience with front room and/or back room compliance audit support.
- Familiarity with Statistical analysis (capability, TMV, appropriate sample size determination).
We are a global leader in healthcare technology, boldly attacking the most challenging health problems facing humanity. Our mission is to alleviate pain, restore health, and extend life. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people.
