Manufacturing Assembly and Validation Specialist

Build with purposeEach 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 missionTurn 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 successAbout 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 scenarioMorning: 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. #J-18808-Ljbffr Connexion