Sustaining R&D Engineer

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

Job summary

Johnson & Johnson’s MedTech division seeks a Sustaining R&D Engineer to lead design and development across the product lifecycle, collaborating with cross-functional teams.

Responsibilities include creating CAD designs, performing testing, and ensuring compliance with MDR and FDA Design Controls, while driving manufacturability and cost improvements. The role is hybrid with onsite days at least 3 per week, based in West Chester, PA.

Qualifications

• 2+ years in design and development of medical devices.
• Mechanical design experience with design controls.
• Understanding of materials, tolerancing, and manufacturing processes.

Responsibilities

• Lead and execute design and development activities across the product life cycle.
• Support MDR, FDA design controls, and regulatory submissions as needed.
• Collaborate with cross-functional teams (Marketing, Quality, Manufacturing, Regulatory).
• Create CAD designs, layouts, tolerancing analyses, and validation plans.
• Develop and execute verification and validation plans and protocols.
• Ensure manufacturability, cost improvements, and production transfers.

Skills

Mechanical design

GD&T

FEA

Prototyping

Design controls

Education

Bachelor's degree in Engineering

Tools

CAD software

Job description

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.

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.

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, draf