Sustaining R&D Engineer - MedTech Implants (Hybrid)

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

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