Medical Device Design Assurance Engineer

Enterra Medical, Inc.; Minneapolis (MN); Hybrid; USD 130,000 - 150,000; Full time

Job summary

Enterra Medical, Inc. in Minneapolis, MN is seeking a Design Assurance Engineer to contribute to all phases of medical device development, including concept, design, prototyping, and manufacturing transfer, with a focus on verification and validation testing.

The role requires strong independent work, effective communication, and experience with verification & validation plans, test fixtures, CAPA, and regulatory filings.

Qualifications

• Bachelor’s degree in engineering or equivalent required.
• Minimum 4 years in medical device, aviation, or military product testing.
• Experience with testing active implantable medical devices preferred.
• Ability to work independently and adapt plans as development inputs change.
• Strong communication skills, both written and spoken.

Responsibilities

• Assist in designing medical devices through testing and validation.
• Develop verification and validation plans and conduct tests.
• Support Design for Manufacturing activities.
• Maintain CAPA records and support product evaluations as needed.
• Coordinate with suppliers and test houses and support regulatory filings.

Skills

Independent work

Effective communication

Test lab experience

Adaptability

Education

Bachelor’s Degree in engineering

Job description

Enterra Medical, Inc. in Minneapolis, MN is seeking a Design Assurance Engineer to contribute to all phases of medical device development, including concept, design, prototyping, and manufacturing transfer, with a focus on verification and validation testing.

The role requires strong independent work, effective communication, and experience with verification & validation plans, test fixtures, CAPA, and regulatory filings.