Sustaining R&D Engineer - MedTech Implants (Hybrid)

jj; West Chester (Chester County); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Johnson & Johnson is seeking a Sustaining R&D Engineer to lead design and development of implants and instrumentation through the product life cycle within a cross-functional team. The role focuses on clinical issues, design parameters, and ensuring the product meets functional requirements for customers including HCPs.

The position involves collaboration with Marketing, Quality, Manufacturing, and Regulatory teams, with a hybrid onsite requirement and travel up to 10%.

Qualifications

• Bachelor’s degree in Engineering required.
• Experience designing medical devices or biomechanical systems.
• Understanding of design controls and tolerancing.
• Experience with MDR/FDA and 510(k) would help.
• Strong communication across functions and with clinicians.

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 partially 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 tolerancing analyses using GD&T; use prototyping, FEA, and simulated-use testing.
• Develop and execute design verification and validation plans, methods, and protocols; analyze results and write technical reports.
• Ensure MDR, FDA Design Controls, and global regulatory requirements, including 510(k) submissions and audits.
• Support supplier, manufacturing, and operations teams to optimize designs for manufacturability and cost.
• Engage Health Care Professionals to define user needs, evaluate prototypes, and support clinical follow-up.
• Participate in complaint investigations, field actions, non-conformance remediation, and quality activities.
• Promote professionalism, ethics, safety, and compliance per company policies.
• Perform special projects and additional duties as assigned.

Skills

Design & development

Mechanical design principles

GD&T

Problem solving

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in Engineering

Mechanical Engineering degree preferred

Tools

Creo/ProE

FEA

Job description

Johnson & Johnson is seeking a Sustaining R&D Engineer to lead design and development of implants and instrumentation through the product life cycle within a cross-functional team. The role focuses on clinical issues, design parameters, and ensuring the product meets functional requirements for customers including HCPs.

The position involves collaboration with Marketing, Quality, Manufacturing, and Regulatory teams, with a hybrid onsite requirement and travel up to 10%.