Director, New Product Development R&D, Biosurgery – MedTech

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Enterprise Management

Job Sub Function:

R&D Management

Job Category:

People Leader

All Job Posting Locations:

Raritan New Jersey United States of America

Job Description:

About Surgery

Fueled by innovation at the intersection of biology and technology were 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 thats 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 worlds most prevalent conditions such as obesity cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at 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 to highly 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.

Purpose:

The Director Biosurgery New Product Development (NPD) will lead a multidisciplinary 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 crossfunctional 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 highperforming NPD team; set priorities develop capabilities and manage performance.
• Own the endtoend NPD portfolio from charter approval to postlaunch stabilization ensuring projects meet scope schedule cost and quality targets.
• Translate strategic product roadmaps into actionable stagegate 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 ISO13485ISO13485 ISO14971ISO14971 FDA 21 CFR 820 as applicable).
• Proven strong scientific mindset to drive successful commercial development.
• Partner closely with Front End Innovation to evaluate & derisk new concepts transfer promising technologies into development charters and with Lifecycle Management to support marketed portfolio
• Lead crossfunctional 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 timetomarket 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 multidisciplinary 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 crossfunctional collaboration with R&D Regulatory Quality Manufacturing Clinical and Commercial teams.
• Excellent project portfolio and resource management skills including stagegate governance and milestone management.
• Strong written and verbal communication skills with ability to influence senior stakeholders. Experience with ISO13485 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 timetomarket and achieve postlaunch 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 or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Business Planning Competitive Landscape Analysis Corporate Management Customer Intelligence Design Mindset Developing Others Inclusive Leadership Industry Analysis Interdisciplinary Work Knowledge Networks Leadership Operational Excellence Product Development Product Development Lifecycle Program Management Qualitative Research Relationship Building Research and Development

The anticipated base pay range for this position is :

$164000.00 - $282900.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

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 period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

Director