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Director of Research & Development (New Hope)

Director of Research & Development (New Hope)

Cypress HCMNew Hope, MN, US
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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 developmentsomeone 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 developmentconceptualization, 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

  • Bachelors 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
  • 📍 New Hope, MN - Onsite

    💼 Full-Time | $150,000$200,000 + Bonus + Stock Options

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    Director Of Research • New Hope, MN, US

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