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New York Technology Partners

New York Technology Partners is hiring: Senior Manufacturing Engineer in Burling

New York Technology Partners, Burlington, MA, US

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Job Title: Senior Manufacturing Engineer

Location: Burlington, MA area – 5 days onsite

Position Type: Full time

Job Description:

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.

Thanks!