A leading medical device manufacturer specializing in the design, development, and production of complex catheter systems, implants, and delivery systems used in various medical procedures. The company partners with OEM medical device manufacturers to create highly specialized solutions that meet regulatory standards and healthcare needs.
Job Summary :
Seeking Senior Assemblers to join the team as they expand production across both first and second shifts due to increasing capacity from new contracts. This role is ideal for individuals with advanced assembly skills who can work on intricate and highly regulated medical devices.
Key Responsibilities :
- Assemble high-precision, complex catheter systems under a microscope using tweezers, scalpels, and small hand tools.
- Perform hand soldering and work with adhesives, bluelight drying techniques, and some laser welding.
- Utilize inspection equipment such as calipers, micrometers, CMM (Coordinate Measuring Machine), and vision systems to ensure quality.
- Operate automated equipment, including braiding and shrinking machines.
- Package finished products according to specifications.
- Maintain detailed documentation of assembly processes (both written and digital).
- Follow ISO and FDA regulations to ensure compliance in a highly controlled environment.
- Work within an ERP system (Epicor) to track production data.
- Communicate effectively in English (both written and verbal).
Work Environment :
Cleanroom environment : must wear special suits, hair nets, and designated footwear.Seated position at a bench for extended periods.Highly regulated environment requiring strict adherence to protocols.Certifications in precision assembly, soldering, or medical device manufacturing.Previous experience working with ISO and FDA-compliant processes.