Job Description
Job Description
Lead Assembly Technician is responsible for manufacturing and assembly. Prepare and assemble electro-mechanical and fluidic systems per Standard Operating Procedures (SOPs), Test methods (TMs), Protocols or Engineering Requests to support Operations, R&D and Quality Department. Duties and responsibilities include, but are not limited to:
- Must have solid knowledge of all assembly functions.
- Must maintains required records of production and reports any inconsistencies or equipment issues following standard procedures.
- Troubleshoots problems and makes necessary adjustments to equipment set ups.
- May conduct testing of production output.
- Train other Assembly Technicians of all levels Production processes and proper documentation.
- Coordinate and collaborate with other departments to optimize the efficiency of the department operation.
- Keep abreast of new products and train other Assembly Technicians on new developments.
- Create Work Orders, as necessary.
- Ensure all test equipment is maintained in proper condition.
- Institute daily work schedules for all cleanroom activities and maintain/improve workforce motivation.
- Interface with personnel within manufacturing and other internal departments
- Conduct regular team meetings to communicate with team members about production goals, performance expectations, and any changes or updates to production plans or processes.
- Adhere to applicable GMP and ISO rules and regulations
- Able to work independently and as well as a team player.
- Perform miscellaneous task as assigned by supervisor
- Ensure that the department follows compliance of all company policies.
- Maintain compliance with Quality System procedures and company policies
Education and/or Work Experience Requirements:
- High School diploma or equivalent experience
- 6+ years’ experience in medical devices manufacturing.
- Must be familiar with FDA/GMP regulations.
- Able to read and write English language work instructions and technical drawings (including schematics), specifications and forms.
- Must be able to use lab equipment and basic hand tools such as microscope, oven, DI water system, sealer, screwdriver, and wrench.
- Must be proficient in using all lab equipment and computers in the cleanroom.
- Must be fully cross functional on all key assembly lines to include certifications (Apical, CleanFlow Assembly)
- Must be able to provide technical and operational knowledge on each function in the cleanroom
- Must have the ability to confidently navigate thru QCBD and have an understanding to use QAD Software Systems
Physical Requirements:
- Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
- Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
- Must be able to safely move up to 25 lbs
- The ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations.
- Must be able to remain in a stationary position for 50% of the time.
- Must be able to occasionally move about inside the office to access file cabinets, office machinery, etc.
- The ability to observe details at close range (within a few feet of the observer).
1st shift 5AM to 1:30PM