🚀 Senior Manufacturing Engineer – Medical Device

Senior Manufacturing Engineer – Medical Device

This range is provided by FUSTIS LLC. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$130,000.00/yr - $130,000.00/yr

• Position: Senior Manufacturing Engineer – 7+ years of medical device experience
• Location: Burlington, MA area
• Duration: Full-Time/Direct (W2)
• Domain: Medical Device
• Interview: Teams Meetings (2) – then potential onsite interview (client pays)
• Salary: $130K, 10% bonus
• VISA: US, Green Card, no GC_EAD

Industries/Domains to target

• Medical Device

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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Information Technology

Industries

• Staffing and Recruiting

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