Medical Device Assembly Technician (GMP/FDA)

Job Description

Job Description

Medical Device Assembly Technician (GMP/FDA)

Picture your first hour: you clock in, review the work instructions for your station, confirm your kit has every component it should, and run through key quality checkpoints before the first build. By mid-morning you’re assembling and testing components using hand tools and automated equipment, documenting results precisely. After lunch, you rotate to a kitting task—verifying contents, labeling, and staging materials so the line never slows. Throughout the day, you’re watching for defects, escalating issues, and keeping your space spotless to 6S standards.

What You’ll Do

• Assemble and, when applicable, test medical devices, equipment, and subassemblies following established procedures and quality specifications.
• Interpret job travelers, part specifications, and assembly drawings to execute builds accurately; review quality points within work instructions.
• Use hand tools, power tools, and automated machinery in compliance with GMP and FDA expectations.
• Build electro-mechanical modules from schematics and diagrams, meeting defined tolerances and standards.
• Complete Device History Record (DHR) documentation accurately per unit when included in your station’s instructions.
• Prepare and organize kitting materials; verify completeness and accuracy, maintain stock levels, and label/route kits to downstream teams.
• Handle, store, and move materials and finished goods per guidelines; maintain inventory accuracy and replenish components to keep production flowing.
• Report discrepancies, defects, and nonconformities to Team Leaders; escalate quality concerns promptly.
• Follow all SOPs and work instructions; document activities per company policies and procedures.
• Package and label components or finished assemblies for shipment; palletize safely in accordance with SOPs.
• Participate in lean and 6S initiatives to increase safety, quality, and efficiency.

How You Work

• Read and comprehend detailed instructions and drawings.
• Detect visual defects quickly and consistently.
• Collaborate with peers, Team Leaders, and supervisors; communicate clearly on a fast-moving line.
• Troubleshoot minor issues and adapt to new processes, tools, and station changes.
• Complete required training and certifications on schedule.
• Champion Environmental Health & Safety practices with a zero-harm mindset; report hazards, near misses, and incidents promptly.

Physical Demands

• Prolonged standing for most of the shift (approximately 8–12 hours, depending on station and shift).
• Frequent walking within production areas to access workstations, retrieve materials, and transport products.
• Lifting and carrying materials or components typically up to 25–55 lbs., with frequent handling of lighter items under 25 lbs.
• Team-lift or approved lifting equipment required for items over 40 lbs. per ergonomics policy.

Qualifications

• Accredited High School Diploma or GED.

Shifts

• 1st Shift: 6:30 AM – 3:00 PM (Monday – Friday)
• 2nd Shift: 2:55 PM – 11:25 PM (Monday – Friday)
• 3rd Shift (Cuffs): 11:20 PM – 7:50 AM (Sunday – Thursday)

Our Commitment to Quality and Safety

Every team member shares responsibility for Good Manufacturing Practices (GMP), regulatory performance, and ethical conduct. You’ll ensure compliance with applicable regulations and internal standards while keeping your work area clean, organized, and audit-ready.