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

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.
• Other duties as required.

Requirements:

• Bachelor’s Degree in engineering
• Minimum of 4 years of experience in medical device, aviation or militaryproduct 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

Compensation: $130,000-150,000 + Bonus DOE