Manufacturing Engineer

Fusion Life Sciences technologies LLC; Raynham (MA); On-site; USD 69,000 - 76,000; Full time

Benefits offered by this job

W-2 employment

Medical device industry exposure

Job summary

Fusion Life Sciences Technologies LLC in Raynham, MA is seeking a Manufacturing Engineer for a 12-month contract. You will own manufacturing process and equipment design from concept through validation and release, leading URS, risk assessments, FAT, SAT, IQ, OQ, and PQ for new equipment and automation systems.

The role demands 5+ years in a regulated manufacturing setting, with experience in change control, deviation investigations, and continuous improvement, and a strong grasp of FDA, ISO,

Qualifications

• 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.

Responsibilities

• 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.

Skills

Manufacturing engineering

Validation documentation

Regulatory knowledge

Job description

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

Why this job is worth considering

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.

What you'll be doing

• 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.

What we're looking for

Required

• 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.

Pay, benefits and schedule

$50–$55 per hour, on a 12-month contract.

Fusion Life Sciences Technologies LLC is a staffing and workforce-solutions firm placing engineers and technical professionals with regulated life sciences, medical device, and pharmaceutical companies, with clients worldwide. Engineers are placed on a W2 basis, not as 1099 contractors, and Fusion's placements span manufacturing process setup, quality and compliance, regulatory affairs, and FDA remediation work governed by frameworks like 21 CFR Part 820, ISO, GAMP, and USP. This Manufacturing Engineer role is a client placement supporting a regulated medical device manufacturing site.