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Enterra Medical Inc is Hiring a Design Assurance Engineer Near Minneapolis, MN
Enterra Medical, an emerging, U.S. based medical device company, markets a novel, implantable neurostimulator focused on the treatment of nausea and vomiting secondary to Gastroparesis. The Enterra Medical business was launched as an independent company in January of 2022, spinning out of Medtronic.The Design Assurance Engineer will 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