Manufacturing Engineer – Medical Devices (12-Month Contract)

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

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,