R&D Engineer; Local to Maple Grove, MN

Position Summary

The R&D Engineer will support the design, maintenance, and continuous improvement of Intravascular Lithotripsy (IVL) and related accessories, with a primary focus on sustaining engineering activities for the manufacturing line. This role requires a senior‑level engineer who can work independently, collaborate cross‑functionally, and effectively support manufacturing, quality, and design stakeholders, including a junior resource to assist with related tasks.

• Provide engineering support to the manufacturing line for the Intravascular Lithotripsy (IVL) and associated accessories.
• Update and maintain engineering drawings and prints to support manufacturing, quality improvements, and design changes.
• Serve as an engineering liaison with contract manufacturers and internal operations and design teams.
• Support CAPAs, nonconformance investigations, and root cause analyses as needed.
• Contribute to manufacturing issue resolution, process improvements, and product sustainment activities.
• Ensure engineering documentation complies with applicable quality system and regulatory requirements.

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a related discipline.
• 3–5 years of experience in the medical device industry.
• Senior‑level engineer with the ability to take direction while also working independently and proactively.
• Demonstrated experience creating, updating, and interpreting engineering drawings/prints (required).
• Experience supporting manufacturing operations and working with contract manufacturers.
• Strong communication skills and ability to collaborate effectively across engineering, quality, and operations teams.
• Experience supporting Class II or Class III medical devices.
• Familiarity with CAPA processes, investigations, and quality systems in a regulated environment.
• Hands‑on experience in sustaining engineering or manufacturing support roles.

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The employee may be required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds.