Assembly Technician

Overview:

Duties & Responsibilities:

• Assemble plastic and metal components into medical devices in accordance with approved manufacturing procedures.

• Utilize small hand tools (both manual and electric), manual presses, assembly fixtures, calibrated instruments, measurement equipment, microscopes, and test fixtures.

• Utilize documentation such as Bill of Materials, product flow charts, work orders, check sheets, visual aids, production reports, and assembly drawings to assemble the product and record results.

• May perform soldering, fabricating, crimping, mechanical assembly, sealing, ultra-sonic welding, bonding and gluing with adhesives, Epoxy or RTV.

• Kitting assemblies using a parts list, scanner and inventory software as required.

• Participates in any routine start up or end of day equipment inspections or verifications.

• Inspects work throughout the assembly process and communicates any quality or operational issues to appropriate leader.

• Maintain neat, orderly and clean work area to ensure efficiency and no safety hazards. Participate in safety programs, meetings, and trainings as required. Bring safety concerns to the attention of management.

• Participate in continuous improvement activities as part of a cross-functional team.

• Meet all quality, quantity and good manufacturing practices to satisfy customer and Regulatory Affairs requirements. Read and/or understand operating procedures for specific products where training has been completed.

• Show constant attention to detail, and immediately inform supervisor of anything out of the ordinary, or anything which does not conform to the approved process sheets.

• Work with Engineers and line leads to resolve issues and correct procedures to ensure quality and efficiency.

• Maintain Clean Room integrity by using proper attire and adherence to Clean Room environment practices and procedures as applicable.

• Maintain accurate records/documentation related to quality, work in progress, test results, labor (e.g. timecards), and special projects.

• Adhere to general safety rules, manufacturing procedures, company policies and procedures, ISO, QSR, and FDA regulations.

Qualifications:

• Minimum of 2 years hands-on experience in a manufacturing environment

• Experience with assembly, testing and the documentation of mechanical and electrical devices

• Exceptional interpersonal, verbal, and written communication skills are required

• Willingness to undertake various tasks and adapt to unexpected situations within a dynamic company environment

• Medical device manufacturing experience preferred

• Working knowledge of the medical device regulatory procedures, lean manufacturing, and manufacturing processes is preferred

• Good hand-eye coordination and manual dexterity required

• Small parts assembly and able to work under a microscope

• Utilize tweezers, torque drivers, magnifiers, and microscopes