🚀 Senior Manufacturing Engineer

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

Location: Burlington, MA – 5 days onsite

Position Type: Full time

Seniority level: Mid‑Senior level

Employment type: Contract

Job function: Information Technology

Industries: Medical Equipment Manufacturing

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.

Benefits

• Medical insurance
• Vision insurance
• 401(k)