Director of R&D

Job Description Job Description 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