MedTech Sustaining R&D Engineer – Design & Compliance

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

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.