Technical Lead, New Product Development R&D, Biosurgery – MedTech

Johnson & Johnson Innovative Medicine•Raritan, NJ

1d•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com 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. About Surgery 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. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for Technical Lead, 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. 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. Position summary We are seeking a driven Technical Leader to serve as the primary technical lead for a new product development project within Biosurgery. This individual will pull together technical input from formulation chemistry, mechanical/device engineering, process development, and other key technical functions to create and execute an integrated project plan. The role requires hands-on technical judgment, strong cross‑functional coordination, and accountability for delivering technically robust, manufacturable, and regulatory‑ready products on schedule and within budget.

Requirements

BS/MS/PhD in Engineering (Biomedical, Mechanical, Chemical), Materials Science, Chemistry, or related technical discipline. (Level of degree vs. experience considered in hiring decision.) is required.
8+ years (BS) or 6+ years (MS/PhD) of industry experience in new product development for medical devices, combination products, or biomaterials is required.
Demonstrated experience acting as technical lead or technical program manager on device or combination‑product development projects with cross‑functional teams is required.
Strong technical background across formulation chemistries, device mechanics, process development, materials, and analytical characterization — or proven ability to assimilate and integrate those domains is required.
Practical experience with design controls, risk management (e.g., DFMEA), verification/validation planning, and regulatory submission support is required.
ISO 13485, FDA 21 CFR knowledge is preferred.
Excellent written and verbal communication skills; ability to synthesize technical input for senior stakeholders and governance forums.
Proven problem‑solving skills, data‑driven decision making, and ability to drive technical consensus among stakeholders.
Office and laboratory environment with hands‑on involvement in experiments and prototype testing.
Travel up to 25% to manufacturing sites, suppliers, or partner locations is required.

Nice To Haves

Direct experience in biosurgery product types (hemostats, sealants, adhesives, hydrogels) or related surgical devices is preferred.
Track record of taking products from concept to commercialization is preferred.

Responsibilities

Act as the single technical lead and owner for an assigned new product development project from concept through transfer to manufacturing and stabilization.
Develop and maintain the integrated technical project plan, including milestones for formulation, device design, process development, characterization, verification/validation, etc.
Facilitate cross‑functional technical decision‑making by coordinating inputs from formulation chemistry, mechanical/device engineering, process engineering, biocompatibility, design quality, technical operations, and pre-clinical teams.
Identify, prioritize, and manage technical risks; define mitigation plans, contingency strategies, and escalation pathways.
Translate product requirements into technical specifications, design inputs, and test plans; lead design reviews and technical gating decisions.
Oversee hands‑on technical work as needed (experimental design, data interpretation, troubleshooting) and ensure rigorous use of design controls and documentation practices.
Lead vendor selection and technical management of external partners (CDMOs, suppliers, testing labs); define acceptance criteria and oversee technology transfer.
Ensure alignment between development activities and downstream manufacturing capabilities, sterility/sterilization strategy, and supply chain constraints.
Own technical readiness for regulatory submissions and support preparation of technical sections, risk files, and verification/validation documentation.

Benefits

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)).
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: - https://www.careers.jnj.com/employee-benefits