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190000WE Requisition #
Thanks for your interest in the Quality Engineer position. Unfortunately this position has been closed but you can search our 2,001 open jobs by clicking here.

Must Have

Job Responsibilities

  • Review new and modified product design documentation for quality characteristics,including manufacturability, serviceability, testability, reliability, and product requirements.
  • Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards.
  • Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
  • Partner with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews occur, and to demonstrate software capability and maturity.
  • Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
  • Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
  • Review Design History Files and Technical Files for conformance to applicable requirements.
  • Participate and provide input to training on department / division procedures and policies.
  • Participate when appropriate in internal audits
  • Medical Devices experience.

Minimum Qualifications

  • B E or B.Tech
  • Minimum 3-4 years of quality engineering experience or equivalence and overall 5-7 years of experience
  • Previous experience working in a cross-functional team environment.
  • Familiar with statistical software tools (Minitab, Stat Graphics)
  • Familiar with ISO 13485, IEC 60601, IEC 62304 and product specific industry standards.
  • Hands-on experience on EU MDR.
  • Computer literate and experience with PCs, networks, and applicationssome travel required
  • Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
  • Good verbal and written communication skills including protocol / report development andtechnical presentations.
  • Risk Management, ISO 14971

Nice to Haves

  • ASQ CQE, CQA, CSQE and/or CRE certification.

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of  what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.  We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.  Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the


Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.

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Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.


The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

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Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

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Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

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Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

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Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

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Our employees come from varied backgrounds with a common goal—changing lives.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.


Be part of one of the world’s leading medical technologies and solutions companies.