Job Details

We are looking for a proven R&D leader to drive the development of a highly advanced Class III medical devices through concept, preclinical, and clinical stages to FDA PMA approval. The ideal candidate has deep expertise in design controls, system development, and design architecture, with hands-on experience managing GLP animal studies, clinical testing, and regulatory submissions. This is a high-impact leadership role shaping next-generation life-sustaining technologies.

Position Summary: The Director of Research & Development will lead the design, development, and advancement of innovative Class III medical devices through all stages of the product lifecycle. This role is responsible for ensuring compliance with FDA regulations and global standards, driving R&D strategy, and managing cross-functional teams to deliver safe, effective, and commercially viable products. The ideal candidate will have deep expertise in design controls, system development, and design architecture, with a proven track record of successfully bringing FDA PMA devices through preclinical and clinical evaluation to approval.

Key Responsibilities:

• Provide strategic leadership and technical oversight for all R&D activities, from concept through commercialization.
• Oversee design controls, system development, design architecture, and product lifecycle management in compliance with FDA QSR, ISO 13485, and applicable standards.
• Lead planning, execution, and reporting of GLP animal studies, preclinical testing, and clinical studies.
• Partner with Regulatory Affairs and Clinical teams to support FDA PMA submissions and interactions with regulatory agencies.
• Direct cross-functional project management efforts, ensuring projects are delivered on time, within budget, and to specification.
• Guide system-level design reviews, risk assessments, and design verification/validation activities.
• Develop and mentor high-performing engineering and scientific teams, fostering innovation and technical excellence.
• Collaborate with internal and external stakeholders, including physicians, investigators, CROs, and key opinion leaders.
• Monitor and evaluate emerging technologies, competitive products, and industry trends to inform R&D strategy.

Qualifications:

• Bachelor's or Master's degree in Engineering, Biomedical Engineering, or related technical discipline (PhD preferred).
• Minimum 10+ years of progressive R&D experience in medical devices, with at least 5 years in a leadership role.
• Proven track record leading development of FDA PMA devices, from concept through clinical evaluation and approval.
• Strong knowledge of FDA design controls, 21 CFR Part 820, ISO 13485, and risk management standards (ISO 14971).
• Direct experience managing GLP animal studies, preclinical testing, and clinical trials.
• Demonstrated ability to manage complex system development and design architecture processes.
• Skilled in project management, resource planning, and cross-functional leadership.
• Excellent communication, collaboration, and problem-solving skills.

Preferred Qualifications:

• Experience with implantable or life-sustaining devices.
• Strong network with clinical and research partners.
• Familiarity with international regulatory submissions (CE Mark, MDR, etc.).