POSITION DESCRIPTION:

Sr. Design Assurance Engineer for Medtronic, Inc., located in Mounds View, MN. Responsible for the 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, ensuring that all finished goods and processes meet specifications. 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 mgmt. 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. Position permits a hybrid model, requiring 2-3 days per week on site. #LI-DNI

BASIC QUALIFICATIONS:

Requires a 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. Must possess at least two (2) years of experience with each of the following: Reliability Engineering for Class II and III Medical Devices; QSR 21 CFR Part 820, ISO 13485, EU MDR, ISO 14971, and GMP; Product Risk Documentation; Non-Conformances, complaints and CAPA; DMAIC, Root Cause Analysis, 5Whys, Fishbone and cause mapping; DOE; product design verification and validation; and sustaining & product Surveillance initiatives. Position permits a hybrid model, requiring 2-3 days per week on site.
Salary: $123,800 to $152,400 per year

Please refer the Job description for details