Technical Lead, New Product Development R&D, Biosurgery – MedTech
Johnson & Johnson, Raritan, NJ, United States
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.
Our inclusive work environment respects diversity, dignity, and individual merit.
Job Function R&D Product Development
Job Sub Function Multi-Family R&D Product Development
Job Category People Leader
Location Raritan, New Jersey, United States of America
About Surgery We’re developing the next generation of smarter, less invasive, more personalized treatments at the intersection of biology and technology. As a Technical Lead, you will deliver surgical technologies and solutions to surgeons and healthcare professionals worldwide, helping treat prevalent conditions such as obesity, cardiovascular disease, and cancer.
Position Summary We seek a driven Technical Leader to serve as the primary technical lead for a new product development project within Biosurgery. The role pulls together technical input from formulation chemistry, mechanical/device engineering, process development, and other key functions to create and execute an integrated project plan.
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.
Qualifications
BS/MS/PhD in Engineering (Biomedical, Mechanical, Chemical), Materials Science, Chemistry, or related technical discipline.
8+ years of industry experience in new product development for medical devices, combination products, or biomaterials (6+ with an MS/PhD).
Demonstrated experience acting as technical lead or technical program manager on device or combination‑product development projects with cross‑functional teams.
Strong technical background across formulation chemistries, device mechanics, process development, materials, and analytical characterization.
Practical experience with design controls, risk management (e.g., DFMEA), verification/validation planning, and regulatory submission support; ISO 13485, FDA 21 CFR knowledge preferred.
Excellent written and verbal communication skills and ability to synthesize technical input for senior stakeholders.
Proven problem‑solving skills, data-driven decision making, and ability to drive technical consensus.
Direct experience in biosurgery product types (hemostats, sealants, adhesives, hydrogels) or related surgical devices preferred.
Track record of taking products from concept to commercialization preferred.
Hands‑on laboratory environment experience.
Travel up to 25 % to manufacturing sites and partner locations.
Benefits Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
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 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 calendar year
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.
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Our inclusive work environment respects diversity, dignity, and individual merit.
Job Function R&D Product Development
Job Sub Function Multi-Family R&D Product Development
Job Category People Leader
Location Raritan, New Jersey, United States of America
About Surgery We’re developing the next generation of smarter, less invasive, more personalized treatments at the intersection of biology and technology. As a Technical Lead, you will deliver surgical technologies and solutions to surgeons and healthcare professionals worldwide, helping treat prevalent conditions such as obesity, cardiovascular disease, and cancer.
Position Summary We seek a driven Technical Leader to serve as the primary technical lead for a new product development project within Biosurgery. The role pulls together technical input from formulation chemistry, mechanical/device engineering, process development, and other key functions to create and execute an integrated project plan.
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.
Qualifications
BS/MS/PhD in Engineering (Biomedical, Mechanical, Chemical), Materials Science, Chemistry, or related technical discipline.
8+ years of industry experience in new product development for medical devices, combination products, or biomaterials (6+ with an MS/PhD).
Demonstrated experience acting as technical lead or technical program manager on device or combination‑product development projects with cross‑functional teams.
Strong technical background across formulation chemistries, device mechanics, process development, materials, and analytical characterization.
Practical experience with design controls, risk management (e.g., DFMEA), verification/validation planning, and regulatory submission support; ISO 13485, FDA 21 CFR knowledge preferred.
Excellent written and verbal communication skills and ability to synthesize technical input for senior stakeholders.
Proven problem‑solving skills, data-driven decision making, and ability to drive technical consensus.
Direct experience in biosurgery product types (hemostats, sealants, adhesives, hydrogels) or related surgical devices preferred.
Track record of taking products from concept to commercialization preferred.
Hands‑on laboratory environment experience.
Travel up to 25 % to manufacturing sites and partner locations.
Benefits Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
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 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 calendar year
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.
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