GMP Cleanroom Production Technician, Medical Devices

Job Description

Job DescriptionDo you thrive in a cleanroom and love building things that save lives?

If you’re drawn to precision work, clear instructions, and visible impact, this role puts you at the center of medical device production. You’ll assemble, test, and document electromechanical components from start to finish.

Opportunity: Contract-to-Perm
Shifts: 1st, 2nd, and 3rd

Imagine this scenario

You begin your shift, gown up, and verify your station. A new work order lands: you review the BOM, flow chart, and assembly drawing, then kit parts with a scanner and inventory software. Using microscopes, measurement tools, and calibrated instruments, you assemble plastic and metal components, perform an ultrasonic weld, and apply Epoxy per spec. You document test results, flag an out-of-spec reading to the line lead, help an Engineer adjust a fixture, and close with end-of-day equipment checks—ready for the next team.

What you’ll handle

• Cleanroom discipline: proper attire and compliance with environmental protocols at all times.
• Assembly: convert plastic/metal components into finished medical devices using approved procedures.
• Tooling: manual/electric hand tools, manual presses, assembly fixtures, calibrated and measurement instruments, microscopes, and test fixtures.
• Documentation: BOMs, product flow charts, work orders, check sheets, visual aids, production reports, and assembly drawings.
• Processes you may run: soldering, crimping, mechanical assembly, sealing, ultrasonic welding, bonding, and adhesive application (Epoxy, RTV).
• Kitting: assemble kits via parts lists, scanners, and inventory systems.
• Equipment care: participate in routine start-up and end-of-day inspections/verifications.
• Quality: inspect in-process work; communicate issues immediately to the appropriate leader.
• Safety and 5S: maintain a tidy, hazard-free area; attend safety meetings/training and raise concerns.
• Continuous improvement: contribute within cross-functional teams to streamline flow and elevate quality.
• Compliance: meet quality, output, and GMP expectations to satisfy customer and Regulatory Affairs requirements; follow operating procedures for products you’re trained on.
• Attention to detail: report anything abnormal or nonconforming to process sheets without delay.
• Collaboration: partner with Engineers and line leads to refine procedures and remove bottlenecks.
• Records: capture quality data, WIP, test results, labor/timecards, and special project notes accurately.
• Regulatory: follow company policies, manufacturing procedures, and applicable ISO, QSR, and FDA regulations.

What makes you successful

• Minimum 2 years of hands-on manufacturing experience.
• Background in assembly, testing, and documentation for mechanical/electrical devices.
• Clear communicator—interpersonal, verbal, and written skills.
• Flexible and proactive in a dynamic, fast-moving environment.
• Nice to have: medical device manufacturing experience.
• Nice to have: knowledge of medical device regulatory procedures, lean manufacturing, and core production processes.
• Steady hands and strong hand–eye coordination; comfortable with small parts under a microscope.
• Fluent with tweezers, torque drivers, magnifiers, and microscopes.

Ready to bring calm focus and technical skill to a cleanroom where every detail matters? Let’s build life-changing products together.