Manufacturing Engineer
-
Engineering
Job Description & How to Apply Below
Updated October 1, 2026
At a glance
Company: Fusion Life Sciences Technologies LLC
Location: Raynham, MA 02767
Pay: $50 - $55 per hour
Job Type: Contract (12 months)
Experience: 5+ years
This Manufacturing Engineer opening supports new product introductions, site capacity expansion, and transformational initiatives inside a regulated medical device manufacturing environment in Raynham, MA. You'd own manufacturing process and equipment design from concept through process qualification and commercial release, and lead the full validation lifecycle - URS, risk assessments, FAT, SAT, IQ, OQ, and PQ - for new equipment and automation systems.
It's a cross-functional role: you'll work directly with internal stakeholders and outside suppliers to resolve technical issues and keep projects on track, with a direct hand in change control, deviation investigations, and continuous improvement. This is a 12-month contract paying $50-$55 per hour for someone with 5+ years in a regulated manufacturing setting.
- Develop and implement advanced manufacturing technologies supporting new product introductions, site capacity expansion, and transformational initiatives in a regulated medical device environment.
- Design manufacturing processes and equipment solutions for manufacturability, scalability, quality, and regulatory compliance from concept through process qualification and commercial release.
- Lead engineering activities and deliverables across cross-functional project plans, keeping scope, timelines, and business objectives aligned.
- Author, review, and execute validation lifecycle documentation, including URS, risk assessments, FAT, SAT, IQ, OQ, and PQ.
- Develop and maintain manufacturing procedures, work instructions, process specifications, and supporting documentation.
- Coordinate qualification and commissioning activities for manufacturing equipment, automation systems, utilities, and supporting software applications.
- Interface with internal stakeholders and external suppliers to resolve technical issues and drive successful project execution.
- Support change control, deviation investigations, root cause analysis, risk assessments, and continuous improvement initiatives.
- Review technical drawings, equipment designs, and vendor documentation for compliance with approved requirements and quality standards.
- 5+ years of experience in manufacturing engineering within a regulated environment (medical device, pharmaceutical, or similar).
- Experience authoring and executing validation lifecycle documentation: URS, risk assessments, FAT, SAT, IQ, OQ, and PQ.
- Working knowledge of FDA regulations, ISO standards, and GMP requirements.
- Experience with change control, deviation investigations, and root cause analysis.
$50-$55 per hour, on a 12-month contract.
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