Job Description

Senior Manufacturing Engineer

Location: Burlington, MA

Domain: Medical Device manufacturing.

Needs to have 9+ years of medical device experience

Senior Manufacturing Engineer – Medical Device (Hands-On Role)

We’re seeking a hands-on Senior Manufacturing Engineer to support daily production and process improvement for medical devices, ensuring compliance with FDA and ISO 13485 standards.

Responsibilities:

• Develop, validate, and improve manufacturing processes and equipment (IQ/OQ/PQ).
• Work directly on the production floor to troubleshoot and resolve process and quality issues.
• Lead root cause investigations and implement corrective/preventive actions.
• Partner with Quality, R&D, and Operations to support design transfer and new product builds.
• Maintain accurate documentation, including DHRs, BOMs, and process instructions.

Qualifications:

• Bachelor’s degree in Engineering and 7+ years of medical device manufacturing experience.
• Strong understanding of GMP, FDA 21 CFR 820, and ISO 13485 requirements.
• Proven ability to work cross-functionally and solve complex process problems.

Hands-on NPI (New Product Introduction) experience is a major plus.

Skills:

• ISO 13485:
• Medical Device:
• QMS:
• DHR:
• BOM’s:
• Solidworks:
• Cost Out:
• Circuit Board Fault Diagnosis
• PCB Fault Detection:
• Board-Level Troubleshooting:
• Board-Level Failure Analysis:
• Electronic Board Fault Localization:
• Circuit Board Debugging:

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