R&D Engineer

Position Summary:

We are seeking a passionate and driven R&D Engineer to join our growing team in Minneapolis. This role offers the opportunity to contribute directly to the development of innovative medical technologies from concept through commercialization. The ideal candidate is hands-on, collaborative, and motivated by making an impact in patient care through engineering excellence.

Key Responsibilities:

• Participate in the design, development, and testing of medical devices and systems.

• Support product development from concept, feasibility, prototyping, and verification through to clinical and commercial launch.

• Collaborate with cross-functional teams including Quality, Regulatory, Manufacturing, and Clinical Affairs.

• Conduct and document design verification and validation activities in compliance with applicable standards and design controls (e.g., ISO 13485, FDA 21 CFR Part 820).

• Analyze test results and translate findings into actionable design improvements.

• Create and maintain engineering documentation such as specifications, drawings, and test reports.

• Assist in root cause analysis and problem-solving for technical issues.

• Contribute to continuous improvement initiatives and design for manufacturability.

Qualifications:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related discipline (Master's preferred).

• 2-7 years of experience in R&D, ideally in the medical device or life sciences industry.

• Experience with CAD tools (e.g., SolidWorks) and engineering analysis software.

• Knowledge of design controls, risk management (ISO 14971), and product development processes in a regulated environment.

• Strong communication and documentation skills.

• Ability to thrive in a fast-paced, collaborative, and hands-on startup or small team environment.