What are the responsibilities and job description for the Electro-Mechanical Build Specialist, Cleanroom Manufacturing position at Connexion?
Be the Link Between Design and Device
Join a team where precision work directly supports patient safety. You’ll turn parts into life-improving medical devices while championing quality, safety, and continuous improvement.
What You’ll Do
- Assemble plastic and metal components into medical devices following approved manufacturing procedures and GMP
- Use documentation (Bill of Materials, product flow charts, work orders, check sheets, visual aids, production reports, assembly drawings) to guide builds and record results
- Execute micro-assembly and inspection using microscopes and magnifiers
- Perform hands-on techniques: soldering, fabricating, crimping, mechanical assembly, sealing, ultrasonic welding, and adhesive bonding with epoxy/RTV
- Kit assemblies accurately with a parts list, scanner, and inventory software
- Complete start-up and end-of-day equipment inspections/verifications
- Conduct in-process inspections; raise quality or operational concerns to the appropriate leader
- Collaborate with Engineers and line leads to resolve issues and optimize procedures
- Maintain a neat, orderly, and clean workstation; engage in safety programs, meetings, and trainings; escalate safety concerns
- Safeguard Clean Room integrity through proper gowning and adherence to cleanroom practices
- Contribute to cross-functional continuous improvement efforts
- Maintain complete, accurate records for quality, WIP status, test results, labor (e.g., timecards), and special projects
- Follow safety rules, manufacturing procedures, company policies, and ISO, QSR, and FDA requirements
Tools & Fixtures You’ll Handle
- Small hand tools (manual and electric), manual presses, and assembly fixtures
- Calibrated instruments, precision measurement equipment, and test fixtures
- Microscopes, magnifiers, tweezers, and torque drivers
What You Bring
- 2 years of hands-on manufacturing experience
- Experience assembling, testing, and documenting electro-mechanical/mechanical devices
- Strong verbal, written, and interpersonal communication skills
- Flexibility to take on varied tasks and adapt in a dynamic environment
- Preferred: prior medical device manufacturing experience
- Preferred: working knowledge of medical device regulatory procedures, lean manufacturing, and core manufacturing processes
- Excellent hand-eye coordination and manual dexterity; comfortable working with small parts under a microscope
- Facility with tweezers, torque drivers, magnifiers, and microscopes
Success Looks Like
- Consistent conformance to approved process sheets and operating procedures
- Proactive identification and communication of nonconformances
- On-time, high-quality builds that meet customer and Regulatory Affairs expectations