MSAT Engineer

Duration of the contract: until 31st December 2026

Hours per week: 40 hours

Essential:
English & German, previous medical device experience / GMP environment, experience in design controls, qualification, validation, tech transfer

Imagine your next project helping to deliver the breakthroughs of tomorrow by ensuring the stability and quality of life‑changing combination products.

As a Device Engineer, you will deliver hands‑on engineering support and technical ownership for device components including secondary packaging and assembly processes across internal and external manufacturing partners.

• Provide device lifecycle engineering across product, process and site support for internal and external manufacturing networks.
• Lead and execute manufacturing scale‑up activities (internal and external) to meet global demand; drive technical transfer and qualification tasks.
• Develop and qualify additional tooling, sub‑assembly and assembly capacity in line with quality system requirements.
• Serve as a technical contact and design authority for one or more devices including secondary packaging.
• Lead root‑cause investigations and implement corrective and preventive actions.
• Support assembly sites and contract manufacturers with troubleshooting and process optimization.

You are a technical leader with a proven track record in medical device lifecycle management and a deep understanding of regulatory compliance.

You will also bring:

• BS in Engineering or Science (Mechanical, Biomedical, or Materials preferred).
• Minimum of 5 years' relevant experience in medical device design, development, or technical support.
• Required experience with FDA regulations (CFR Parts 4, 210, 211, 820) and medical device quality systems.
• Fluent in spoken and written English.
• Proven ability to lead root‑cause investigations and implement robust corrective actions.
• Familiarity with ISO 13485 and European medical device regulatory requirements.
• Experience with Six Sigma or equivalent statistical process improvement.
• Project management capability or certification.

Benefits:
This role offers a very competitive hourly rate. This contract will run until 31st December 2026.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.