Job Overview
Director, New Product Development R&D, Biosurgery – MedTech for the handheld medical devices business in Raritan, NJ. The role leads a multi‑disciplinary team of scientists and engineers to advance biosurgery products from charter approval through launch and stabilization. Accountable for technical strategy, project execution, regulatory and quality readiness, and cross‑functional collaboration with Front End Innovation, Lifecycle Management, Process Development, Regulatory, Quality, Manufacturing, Clinical, and Commercial teams to deliver safe, compliant, and competitive products to market.
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, ISO13485, ISO14971, FDA 21CFR820).
- Partner with Front End Innovation to evaluate and de‑risk new concepts, transfer promising technologies into development charters.
- Support Lifecycle Management to advance marketed portfolio, lead cross‑functional launch readiness activities (packaging, sterilization, labeling, clinical support, regulatory submissions).
- Manage budgets, capital requests and external spending on projects and departmental activities.
- 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.
- Ensure safe laboratory operation and compliance with all safety and regulatory requirements.
Qualifications
- Ph.D. degree and 8+ years of relevant experience in Chemistry, Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Materials Science, or related technical discipline.
- 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.
- Demonstrated success leading projects from early development through regulatory submission and commercial launch.
- Strong knowledge of product development lifecycle, design controls, verification & validation, risk management and quality systems.
- Experience with materials/chemistry relevant to biosurgery products (polymers, adhesives, hemostats, tissue sealants, biologic formulations).
- 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 the ability to influence senior stakeholders.
- Experience with ISO13485 and FDA device regulations; experience with combination products or biologic interfaces preferred.
- Experience with external partnerships (CMOs/CDMOs, suppliers, academic collaborations) preferred.
- Proven ability to reduce time‑to‑market and achieve post‑launch stabilization metrics.
- Prior experience implementing continuous improvement or lean product development practices preferred.
Travel
Domestic and international travel up to 25% required.
Salary and Benefits
- Base pay range: $164,000.00 - $282,900.00.
- Vacation: 120 hours per calendar year.
- Sick time: 40 hours per calendar year (48 hours in Colorado, 56 hours in Washington).
- 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 birth/adoption/foster care.
- Bereavement leave: 240 hours for an immediate family member, 40 hours for an extended family member per 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.
Equal Opportunity
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. Johnson & Johnson actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of applicants’ needs. If you have a disability and would like to request an accommodation, please contact us at or contact AskGS to be directed to your accommodation resource.
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