Design Assurance Engineer

Minneapolis, MN

Full Time

Mid Level

Design Assurance Engineer
Location: Minneapolis, MN (hybrid)

Position Overview:

We are seeking a Design Assurance Engineer to be involved in all aspects of medical device development including concept generation, design, prototyping, and manufacturing transfer. The main focus will be performing and supporting verification and validation testing.

Responsibilities:

Assist in the design of cutting-edge medical devices through testing.
Develop verification and validation plans and conduct appropriate testing
Assist in DFM (Design for Manufacturing) activities.
Support CAPA process and product evaluations when needed
Maintain working relationships with Suppliers and outside test houses.
Support regulatory filings to various government bodies.
Other duties as required.

Requirements:

Bachelor’s Degree in engineering
Minimum of 4 years of experience in medical device product testing preferred.
Experience with testing active implantable medical devices preferred
Demonstrated ability for independent work
Knowledge of the design principles
Experience with documented specifications
Experience with mechanical or electrical testing and test fixtures
Ability to independently develop and adapt work plans based input from development engineering
Ability to communicate effectively, orally and in writing
Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
Experience with Verification & Validation plans, reports, and procedures
Test lab experience
Ability to provide timely status reporting

Compensation: $130,000-150,000 + Bonus DOE

#LI-hybrid

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Design Assurance Engineer

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