SENIOR MANUFACTURING ENGINEER
$90,000–$120,000 year
Remote · Gardner, Massachusetts, United States or New York City, New York, United States
Job Summary
The Senior Manufacturing Engineer is responsible for designing, developing, and documenting manufacturing systems and processes. The role requires extensive experience in manufacturing engineering, particularly in the medical device sector, ensuring compliance with FDA regulations and ISO standards, and improving manufacturing efficiency through Lean methodologies. This position does not include supervisory responsibilities and operates in controlled cleanroom environments.
Required Qualifications
- 8+ years of related manufacturing/industrial engineering work experience
- 3+ years of experience with medical devices in FDA QSR & ISO13485 regulated environment
- Experience with manufacturing complex electro-mechanical products
- Proven track record of creating FMEAs and process verification
- Microsoft Office 365 Suite & ERP/PLM proficiency required
- Demonstrated understanding of mechanical dimensioning and tolerancing
Desired Qualifications
- Lean and/or Six Sigma Black Belt certification
- Proficiency with Minitab or other statistical software
- Working knowledge with SolidWorks
- Experience with electronic documentation systems
Additional Requirements
- Applicants must have US citizenship or US person status
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.