New York Technology Partners
New York Technology Partners is hiring: Senior Manufacturing Engineer in Burling
New York Technology Partners, Burlington, MA, US
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!