Manufacturing Assembly and Validation Specialist

Job Description

Job Description

Build with purpose

Each precise connection and verified measurement helps deliver a reliable medical device. In this role, you transform components into finished assemblies while championing documentation, quality, and safety.

Your mission

• Turn plastic and metal parts into medical devices by following approved manufacturing procedures and visual references.
• Operate small hand tools (manual and electric), manual presses, assembly fixtures, calibrated instruments, measurement equipment, microscopes, and test fixtures.
• Leverage documentation—Bill of Materials, product flow charts, work orders, check sheets, production reports, and assembly drawings—to guide builds and record results.
• Apply specialized techniques when needed: soldering, fabricating, crimping, sealing, ultrasonic welding, and bonding/gluing using Epoxy or RTV.
• Execute kitting using parts lists, a scanner, and inventory software.
• Conduct routine start-up and end-of-day inspections/verifications on equipment.
• Inspect work continuously and communicate quality or operational concerns to the appropriate leader without delay.
• Maintain a clean, organized, and safe work area; engage in safety programs, meetings, and trainings; raise safety issues to management.
• Contribute to cross-functional continuous improvement initiatives.
• Achieve required quality and throughput while adhering to Good Manufacturing Practices to meet customer and Regulatory Affairs standards; follow operating procedures for trained products.
• Flag any nonconforming conditions immediately and inform your supervisor.
• Collaborate with Engineers and line leads to resolve issues and optimize procedures for quality and efficiency.
• Keep precise records for quality, work in progress, test data, labor (including timecards), and special projects.
• Comply with safety rules, manufacturing procedures, company policies, and ISO, QSR, and FDA regulations.

What sets you up for success

• About 2 years of hands-on experience in manufacturing.
• Experience assembling, testing, and documenting electromechanical devices.
• Clear, professional communication—interpersonal, verbal, and written.
• Ability to adapt and take on varied tasks in a dynamic environment.
• Preferred: medical device manufacturing experience.
• Preferred: knowledge of medical device regulatory procedures, lean manufacturing, and common manufacturing processes.
• Fine motor skills and strong hand–eye coordination for small-part assembly under a microscope.
• Comfort with tweezers, torque drivers, magnifiers, and microscopes.

Imagine this scenario

Morning: you verify equipment and kit parts using a scanner and inventory software. Midday: a test result looks unusual—you pause, consult the flow chart and drawings, notify the leader, and work with an Engineer and line lead to correct the procedure. End of day: you document results on check sheets and production reports, log timecards accurately, and leave a clean station ready for tomorrow.