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Director R&D
Director R&DEPM Scientific • Minneapolis, MN, US
Director R&D

Director R&D

EPM Scientific • Minneapolis, MN, US
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Position Summary :

We are seeking a visionary and execution-focused Director of R&D to lead the development of a novel medical device platform from the ground up. This is a high-impact, high-visibility role backed by executive leadership at a $10B global medical device company . Unlike a typical director position, this role involves building the R&D site, assembling a world-class team , and defining the product roadmap for the next decade

The successful candidate will be instrumental in shaping the future of the company's innovation pipeline and will have a clear path to long-term leadership within the organization.

Key Responsibilities :

  • Architect and lead the development of a first-of-its-kind medical device platform.
  • Build and scale the R&D site, including hiring and mentoring top engineering and scientific talent.
  • Define and execute a 10-year product development roadmap in alignment with strategic business goals.
  • Oversee all phases of product development : concept, feasibility, design, verification / validation, and transfer to manufacturing.
  • Ensure compliance with global regulatory standards (FDA, ISO 13485, EU MDR).
  • Collaborate closely with Regulatory, Quality, Clinical, and Commercial teams to support submissions and market launches.
  • Drive innovation through technology scouting, IP strategy, and external partnerships.
  • Manage budgets, timelines, and resource allocation across multiple development programs.

Qualifications :

  • Bachelor's degree in Engineering, Biomedical Sciences, or related field (Master's or PhD preferred).
  • 10+ years of experience in medical device R&D, with at least 5 years in a leadership role.
  • Proven success in launching Class II or III devices and scaling R&D operations.
  • Deep understanding of design controls, risk management (ISO 14971), and product lifecycle management.
  • Experience with IQ / OQ / PQ, DHF, and regulatory submissions (510(k), PMA, CE Mark).
  • Strong leadership, strategic thinking, and cross-functional collaboration skills.

    • Preferred Experience :

  • Experience building or scaling R&D teams or facilities.
  • Familiarity with Lean Product Development or Agile methodologies.
  • Prior involvement in strategic planning, M&A, or corporate innovation initiatives

    • Why This Role Is Unique :

  • Executive Sponsorship : Direct support from senior leadership ensures resources and visibility.
  • Strategic Impact : Define the future of a product line with global reach and clinical significance.
  • Career Trajectory : For the right developmental leader, success in this role will solidify a long-term leadership path within a $10B medical device giant.
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    Rd • Minneapolis, MN, US