R&D Engineer (Local to Maple Grove, MN)
Rqm-
- Osseo, Minnesota, United States
- Osseo, Minnesota, United States
Über
Key Responsibilities
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.
Required Qualifications
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.
Work Environment/Physical Demands 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.
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Sprachkenntnisse
- English
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