Design Assurance Engineer

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.
• Provides guidance on software requirements and quality standards.
• Other duties as required.

Requirements:

• Bachelor’s Degree in engineering, electrical or software
• Minimum of 4 years of experience in medical device, aviation or military product testing.
• Experience with testing active implantable medical devices preferred
• Working knowledge of IEC 62304 and ISO 14971
• 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 

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