Director, New Product Development R&D, Biosurgery – MedTech
About The Position
This role will lead a multi-disciplinary team of scientists and engineers to advance biosurgery products from charter approval through launch and stabilization. The 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. The role supports Johnson & Johnson's handheld medical devices business and is located in Raritan, NJ, with a Flex/Hybrid schedule requiring 3 days per week on-site. Relocation assistance is available for highly qualified candidates. The business offers a broad range of products and technologies, including surgical staplers, clip appliers, trocars, and sealing devices, used in various minimally invasive and open surgical procedures.
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 materials/chemistry relevant to biosurgery products (e.g., polymers, adhesives, hemostats, tissue sealants, biologic formulations) is required.
- Track record of cross-functional collaboration with R&D, Regulatory, Quality, Manufacturing, Clinical and Commercial teams.
- Excellent project portfolio and resource management skills, including stage-gate governance and milestone management.
- Strong written and verbal communication skills with ability to influence senior stakeholders.
- Domestic and International travel up to 25% is required.
Nice To Haves
- Experience with ISO 13485 and FDA device regulations; experience with combination products or biologic interfaces is preferred.
- Experience with external partnerships (CMOs/CDMOs, suppliers, academic collaborations) is preferred.
- Proven ability to reduce time-to-market and achieve post-launch stabilization metrics.
- Prior experience implementing continuous improvement or lean product development practices is preferred.
Responsibilities
- 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).
- 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.
Benefits
- Relocation assistance is available to highly qualified candidates.
- Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Vacation – 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
