Senior Manufacturing Engineer Job at MARVEL Infotech Inc., Burlington, MA

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  • MARVEL Infotech Inc.
  • Burlington, MA

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:

Job Tags

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