Director of R&D

18 Days Old

Director of R&D – Medical Devices New Hope, MN Full-Time | $150,000–$200,000 + Bonus + Stock Options A leading medical device company in the Twin Cities is seeking a Director of Research & Development to lead innovation and growth at its New Hope facility. This critical leadership role will oversee a team of approximately 30 engineers, with a strong focus on advancing catheter technologies from concept through to design transfer and manufacturing readiness. We're looking for a hands-on, strategic R&D leader with deep experience in contract manufacturing and medical device development—someone who can both inspire high performance and dive into the technical details alongside the team when needed. Key Responsibilities Lead, mentor, and grow a high-performing R&D engineering team. Recruit and retain top talent while fostering a collaborative, innovation-driven culture. Drive the full lifecycle of catheter development—conceptualization, design, validation, and transfer to manufacturing. Ensure robust product and process development in line with regulatory and customer requirements. Champion cross-functional collaboration to ensure seamless product integration into Operations. Identify and propose new technologies to enhance technical capabilities and business growth. Guide the team through process validation strategies (IQ, OQ, PQ). Support budget planning, project scheduling, and strategic decision-making for R&D initiatives. Qualifications Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline. Minimum 5 years of experience in catheter or medical component development and manufacturing. At least 7 years in a leadership role within an R&D or engineering environment. Proven track record with FDA regulations, design controls, GMP, GDP, and QMS standards. Experience with budgeting, scheduling, and organizational planning. Strong understanding of product and process design within a regulated environment
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Location:
New Hope
Job Type:
FullTime
Category:
Science

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