Full-Time
Design Assurance Engineer
Updated on 9/10/2026
Enterra Medical
51-200 employees
Develops implantable gastric electrical stimulation therapy
Compensation Overview
$130k - $150k/yr
Minneapolis, MN, USA
Hybrid
Three or more days on-site per week required.
Bachelor's
 Biology & Biotech (1) |
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- A bachelor's degree in engineering, electrical engineering, or software engineering.
- A minimum of 4 years of experience in medical device, aviation, or military product testing.
- Working knowledge of IEC 62304 and ISO 14971.
- Experience with design principles and documented specifications.
- Experience with mechanical or electrical testing and test fixtures.
- Ability to independently develop and adapt work plans based on input from development engineering.
- Experience with verification and validation plans, reports, and procedures.
- Test laboratory experience.
- Ability to provide timely status reporting.
- Assist in the design of medical devices through testing.
- Develop verification and validation plans and conduct appropriate testing.
- Assist with design for manufacturing activities.
- Support the corrective and preventive action process and product evaluations when needed.
- Maintain working relationships with suppliers and outside test houses.
- Support regulatory filings to government bodies.
- Provide guidance on software requirements and quality standards.
- Experience testing active implantable medical devices.
Enterra Medical develops the Enterra Therapy system, a gastric electrical stimulation implant for adults with drug-refractory gastroparesis. The system includes a small implant in the lower abdomen and two leads placed into the stomach wall; it sends mild electrical pulses to stomach muscles and nerves and can be adjusted by a physician using an external programmer, with the option to turn off or remove the device. Its approach centers on this specific therapy with ongoing improvements (such as the Enterra II MR Conditional system and the Enterra ReliaStim lead) and collaboration with Medtronic as an operational partner. The goal is to provide a safe, adjustable, and reversible treatment that relieves chronic nausea and vomiting and improves quality of life for patients when other treatments have failed.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
Minneapolis, Minnesota
Founded
2022
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Simplify's Take
What believers are saying
- NAVIGATE enrolled 148 patients across U.S., Europe, and Britain by August 2026.
- Enterra ReliaStim launched January 2026, signaling active product iteration and surgeon workflow gains.
- Expanded MRI labeling in 2023 directly removes a common reason physicians avoid implanted devices.
What critics are saying
- The FDA still says Enterra effectiveness for gastroparesis has not been demonstrated.
- NAVIGATE, started June 2025, must prove chronic-nausea efficacy before label expansion.
- If payer coverage stalls, Enterra remains a niche implant business with limited procedure volume.
What makes Enterra Medical unique
- Enterra Medical owns the only FDA HDE gastroparesis GES franchise since 2000.
- January 2026 Enterra ReliaStim added proprietary lead placement hardware to Enterra Therapy.
- Enterra II MR Conditional approval expanded MRI access, easing a major implant barrier.
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Benefits
Flexible Work Hours
Hybrid Work Options