Sustaining R&D Engineer

Johnson & Johnson Innovative Medicine; West Chester (Chester County); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Johnson & Johnson in West Chester, PA, seeks a Sustaining R&D Engineer to lead lifecycle design and development of implants and instrumentation within a cross-functional team. You will ensure clinical relevance, design for manufacturability, and regulatory compliance, while supporting in-market products through their lifecycle.

The role combines design execution with collaboration across marketing, quality, and regulatory teams, and requires on-site presence at least three days weekly in a

Qualifications

• Bachelor's degree in Engineering or related discipline.
• Minimum of 2 years in design and development of medical devices or biomechanical systems.
• Strong understanding of mechanical design principles, materials, manufacturing processes, tolerancing, drafting standards, and GD&T.
• Willingness to travel at least 10%.

Responsibilities

• Lead and execute design and development activities across the product life cycle, from concept through commercialization and post-market support, as part of cross-functional project teams.
• Technically support and lead projects with oversight, partnering with the Project Leader and Core Team (Marketing, Quality, Manufacturing, Supply Chain, Regulatory).
• Define and develop product requirements and design concepts with internal teams and Health Care Professionals.
• Create CAD designs, layouts, and tolerance analyses using GD&T and prototyping, testing, and analysis.
• Develop and execute design verification and validation plans, methods, and protocols; analyze results and report.
• Ensure MDR, FDA Design Controls, and global regulatory requirements, including support of 510(k) submissions, IDE studies, audits.
• Support suppliers, manufacturing, and operations to optimize manufacturability, cost, and production transfers.
• Engage Health Care Professionals to define user needs, evaluate prototypes, and support clinical follow-up.
• Participate in complaints, non-conformance remediation, and other quality/compliance activities.
• Promote high standards of professionalism, ethics, safety, and compliance.

Skills

Medical device design

GD&T proficiency

Project execution

Cross-functional collaboration

Problem solving

Communication skills

Travel 10%

Education

Bachelor's in Engineering

Mechanical engineering preferred

Tools

CAD tools (Creo/ProE)

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

West Chester, Pennsylvania, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required,

regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

We are searching for the best talent for Sustaining R&D Engineer position.

The Sustaining R&D Engineer helps lead the design and development of new implants and instrumentation and/or support in-market products through their product life-cycle within a cross-functional project team. This includes communication with customers, e.g. Health Care Professionals and marketing, understanding of clinical issues, defining the design parameters, and ensuring the product, which is provided to the customer, meets the functional requirement. Hybrid role allows for minimum 3 days a week onsite.

You will be responsible for:

• Lead and execute design and development activities across the product life cycle, from concept through commercialization and post‑market support, as part of cross‑functional project teams.
• Technically support and partially lead projects with oversight, partnering closely with the Project Leader and Project Core Team (Marketing, Quality, Manufacturing, Supply Chain, Regulatory).
• Define and develop product requirements and design concepts through collaboration with internal teams and Health Care Professionals.
• Create CAD designs, layouts, and tolerance analyses using GD&T; solve design challenges using prototyping, FEA, and simulated‑use, dry, and wet lab testing.
• Develop and execute design verification and validation plans, methods, and protocols; analyze results and author technical reports.
• Ensure compliance with MDR, FDA Design Controls, and global regulatory requirements, including support of 510(k) submissions, IDE studies, audits, and inspections.
• Support supplier, manufacturing, and operations teams to optimize designs for manufacturability, assembly, cost improvement, and production transfers.
• Engage Health Care Professionals to define user needs, evaluate prototypes, and support clinical follow‑up while maintaining awareness of surgical trends.
• Participate in complaint investigations, field actions, non‑conformance remediation, and other quality and compliance‑related activities.
• Promote and adhere to the highest standards of professionalism, ethics, safety, and compliance in accordance with company policies and regulations.
• Perform special projects and additional duties as assigned.

Qualifications / Requirements:

Education

• Bachelor’s degree in Engineering or related discipline required.
• Mechanical Engineering degree or demonstrated mechanics focus preferred.

Experience and Skills

Required:

• Minimum of 2 years of experience in design and development of medical devices, mechanical products, or biomechanical systems.
• Mechanical design experience, including exposure to design controls and development engineering.
• Strong understanding of mechanical design principles, materials, manufacturing processes (particularly machining), tolerancing, drafting standards, and GD&T.
• Demonstrated ability to execute project responsibilities, manage multiple priorities, and overcome technical challenges.
• Strong problem‑solving, decision‑making, and root cause analysis skills.
• Effective written and verbal communication skills, including the ability to communicate technical concepts across functions and with Health Care Professionals.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Ability to work with wet tissue/cadaver labs and within an operating room environment.
• Ability to travel at least 10%

Preferred:

• Knowledge of biomechanics, anatomy, and biology.Familiarity with orthopedic or TECA product portfolios.
• Experience with MDR/FDA regulations, including 510(k) submissions.Proficiency with CAD tools (e.g., Creo/ProE).Experience with design verification/validation, DFMEA/PFMEA, and process validation.
• Experience with implantable medical devices and/or plastic injection molding and design for manufacturability.
• Prior project management experience.Exposure to GMP, QSR, ISO, and good documentation practices (GDP).

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, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

#LI- Hybrid

Required Skills:

Preferred Skills: