Director, New Product Development R&D, Biosurgery MedTech
J&J Family of Companies, Raritan, NJ, United States
Director, New Product Development R&D, Biosurgery MedTech
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 MedTech 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 for qualified candidates. Our business offers a broad range of products and technologies, including surgical staplers, clip appliers, trocars and sealing devicesthat are used in a wide variety of minimally invasive and open surgical procedures. 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), Regulatory, Quality, Manufacturing, Clinical, and Commercial teams to deliver safe, compliant, and competitive products to market. You will be responsible for: 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. Drive technical development activities: formulation/materials selection, prototype/devices, lab and pilot scale process development, verification and validation planning and execution. 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 for 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. Qualifications and requirements: A Bachelors degree with 10+ years of relevant experience or an MS or PhD 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 5 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. 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. Travel: Domestic and International up to 25% is required. 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. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is: $164,000.00 - $282,900.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 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 10 days Volunteer Leave 32 hours per calendar year Military Spouse Time-Off 80 hours per year Please use the following language: For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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 MedTech 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 for qualified candidates. Our business offers a broad range of products and technologies, including surgical staplers, clip appliers, trocars and sealing devicesthat are used in a wide variety of minimally invasive and open surgical procedures. 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), Regulatory, Quality, Manufacturing, Clinical, and Commercial teams to deliver safe, compliant, and competitive products to market. You will be responsible for: 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. Drive technical development activities: formulation/materials selection, prototype/devices, lab and pilot scale process development, verification and validation planning and execution. 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 for 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. Qualifications and requirements: A Bachelors degree with 10+ years of relevant experience or an MS or PhD 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 5 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. 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. Travel: Domestic and International up to 25% is required. 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. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is: $164,000.00 - $282,900.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 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 10 days Volunteer Leave 32 hours per calendar year Military Spouse Time-Off 80 hours per year Please use the following language: For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits