EPM Scientific
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.
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.