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Sr. Design Assurance Engineer
| Company | Medtronic |
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| Location | Blaine, MN, USA |
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| Salary | $123800 – $152400 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Senior |
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Requirements
- Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and two (2) years of experience as a quality or design assurance engineer, or Bachelor’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and five (5) years of experience as a quality or design assurance engineer
- At least two (2) years of experience with Reliability Engineering for Class II and III Medical Devices
- At least two (2) years of experience with QSR 21 CFR Part 820, ISO 13485, EU MDR, ISO 14971, and GMP
- At least two (2) years of experience with Product Risk Documentation
- At least two (2) years of experience with Non-Conformances, complaints and CAPA
- At least two (2) years of experience with DMAIC, Root Cause Analysis, 5Whys, Fishbone and cause mapping
- At least two (2) years of experience with DOE
- At least two (2) years of experience with product design verification and validation
- At least two (2) years of experience with sustaining & product Surveillance initiatives
Responsibilities
- Development, coordination and conducting of technical reliability studies supporting manufacturing operations
- Evaluating compliance of materials and processes with specifications and customer requirements
- Support qualification of Coronary & Renal Denervation (CRDN) medical device components
- Provide Design Assurance support to various Operating Unit (OU) Sustaining & product Surveillance initiatives
- Conduct evaluations of engineering design concepts and design of experiments (DOE) constructs
- Support product design verification and validation
- Coordinate Reliability Engineering for Class II and III Medical Devices
- Navigate the complexities of industry and government regulations to include FDA Quality System Regulation (QSR) 21 CFR 820, ISO 13485, EU Medical Device Regulation (MDR), ISO 14971, State of the Art (SOTA), and Good Manufacturing Practices (GMP)
- Responsible for risk management activities by maintaining product risk documentation
- Evaluate non-conformances, complaints, and corrective and preventative actions (CAPA)
- Leverage process improvement tools including DMAIC, Root Cause Analysis, 5Whys, Fishbone and cause mapping
Preferred Qualifications
No preferred qualifications provided.
