Director, Product Development R&D, Biosurgery – MedTech

Director, New Product Development R&D, Biosurgery – Med Tech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer.

Patients are waiting.

We are searching for the best talent for a Director, New Product Development R&D, Biosurgery – Med Tech to support our handheld medical devices business. This role will be located in Raritan, NJ & work a Flex/Hybrid schedule with 3 days per week on-site. Relocation assistance is available to highly qualified candidates.

Our business offers a broad range of products and technologies, including surgical staplers, clip appliers, trocars and sealing devices—that are used in a wide variety of minimally invasive and open surgical procedures.

Purpose:

The Director, Biosurgery New Product Development (NPD) will lead a multi‑disciplinary team of scientists and engineers to advance biosurgery products from charter approval through launch and stabilization. This leader will be accountable for technical strategy, project execution, regulatory and quality readiness, and cross‑functional collaboration with Front End Innovation (FEI), Lifecycle Management (LCM), Process Development, Regulatory, Quality, Manufacturing, Clinical, and Commercial teams to deliver safe, compliant, and competitive products to market.

You will be responsible for:

• Drive technical development activities with urgency and attention to detail; formulation/materials selection, prototype/devices, lab and pilot scale process development, verification and validation planning and execution.
• Lead, mentor and grow a high‑performing NPD team; set priorities, develop capabilities, and manage performance.
• Own the end‑to‑end NPD portfolio from charter approval to post‑launch stabilization, ensuring projects meet scope, schedule, cost, and quality targets.
• Translate strategic product roadmaps into actionable stage‑gate plans, resource allocation and milestone schedules.
• Ensure design control, risk management, and verification/validation activities comply with applicable standards and regulations (e.g., design controls, ISO 13485, ISO 14971, FDA 21 CFR 820 as applicable).
• Proven, strong scientific mindset to drive successful commercial development.
• Partner closely with Front End Innovation to evaluate & de‑risk new concepts, transfer promising technologies into development charters, and with Lifecycle Management to support marketed portfolio
• Lead cross‑functional launch readiness activities (packaging, sterilization, labeling, clinical support, regulatory submissions, etc.).
• Manage budgets, capital requests and external spending on projects and departmental activities.
• Responsibility for safe laboratory operation
• Represent NPD function in governance forums and provide transparent reporting on portfolio status, risks and mitigation plans.
• Establish and track KPIs for time‑to‑market, launch stabilization (e.g., time to stable production, complaint rates), budget adherence, and technical deliverables.

Qualifications and requirements:

• A Ph.D. degree with 8+ years of relevant experience in Chemistry, Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Materials Science, or related technical discipline is required.
• 8+ years of product development experience in medical devices, biosurgery/biomaterials, or combination products, with at least 3+ years in a leadership role managing multi‑disciplinary teams is required.
• Demonstrated success leading projects from early development through regulatory submission and commercial launch is required.
• Strong knowledge of product development lifecycle, design controls, verification & validation, risk management and quality systems is required.
• Experience with…