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R&D Engineer Mid-Level
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Prevailing Medical
Minneapolis, MN (In Person)
$92,500 Salary, Full-Time
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Job Description
Prevailing Medical is seeking a hands-on R&D Engineer to help develop innovative catheter-based medical devices from concept through commercialization. This role is ideal for an engineer who enjoys solving complex technical challenges, working directly with customers, and making a meaningful impact in a fast-paced environment. Key Responsibilities Lead and support project planning, scheduling, and execution to ensure milestones and deliverables are achieved on time. Design, develop, and refine catheter-based medical devices and manufacturing processes. Drive product development activities from concept through commercialization. Build prototypes and conduct design verification, validation, and performance testing. Create and maintain engineering documentation, including drawings, protocols, reports, risk analyses, and Design History File (DHF) documentation. Collaborate closely with customers, Quality, Regulatory, and Manufacturing teams to ensure project success. Conduct root cause investigations and implement effective corrective actions for technical challenges. Support design transfer activities and product launch into manufacturing. Participate in continuous improvement initiatives to enhance product quality and manufacturing efficiency. Qualifications Required Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline. 3-7 years of medical device R&D experience. Experience with FDA Quality System Regulations and