Design Assurance Engineer
About this role
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.
- Bachelor’s Degree in engineering
- Minimum of 4 years of experience in medical device, aviation or military product testing.
- 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
#LI-hybrid
Company at a glance
Enterra Medical is a medical device company dedicated to a singular focus: helping more people with chronic gastroparesis live better lives by advancing technology, expanding clinical science, and accelerating access to the Enterra® Therapy.*
Gastroparesis is a condition in which food moves through the stomach too slowly, causing chronic nausea and vomiting. Enterra Therapy, approved by the FDA under a Humanitarian Device Exemption in 2000, may be a surgical option for certain people who are unable to control chronic symptoms of gastroparesis.* It is the first and only implantable therapy designed to reduce nausea and vomiting associated with diabetic or idiopathic gastroparesis through gastric electrical stimulation (GES), and over 15,000 people have received Enterra Therapy to help resume everyday activities. Consult with a doctor to see if Enterra Therapy may be an option for you.
*Humanitarian Device. Enterra Therapy is authorized by Federal law for use in the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years. The effectiveness of this device for this use has not been demonstrated. Visit www.enterramedical.com/important-safety-information/ for important safety information.
Top Benefits
- Bonus
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