Principal Senior Development Quality Engineer
1 month ago
Rate: Perm 110k-150k
Location: Arden Hills, MN
Hybrid 3 days in office
Must Haves:
- Bachelor of Science in Industrial, Biomedical, Mechanical, Electrical Engineering, or related degree
- Minimum of 7 years of electrical medical device engineering experience
- Minimum of 7 years of quality assurance experience
- Experience supporting Medical Electrical Equipment (MEE)
- In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements
- Prior leadership roles / experience
Plusses:
- Presentation skills
- Ability to influence cross-functional teams
Day to Day/Core Responsibilities:
The Principal Service Development Quality Engineer will join our client's Medical Electrical Equipment portfolio. This role ensures high-quality products by assisting product and service development teams, reducing service process nonconformances, and implementing corrective actions. Responsibilities include developing service quality plans, monitoring product performance, collecting and analyzing field data, and creating quality tools and training materials. The engineer also evaluates compliance with regulations, participates in global improvement initiatives, supports cross-functional teams, and leads quality improvement projects. Additionally, the role involves supporting internal and external regulatory audits.
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