Title: Contract Manufacturing Associate, Instrument
Work Location: Ann Arbor, MI
Duration: 12 Months
1st shift: 7am – 3:30pm
2nd shift: 3:20pm – 11:50pm
Pay Rate: $17/hr
· Manufacturing Associates are required to have a strong knowledge of manufacturing methods and techniques, process development experience, work flow understanding, ability to read drawings, and to test and calibrate instruments, and troubleshoot electromechanical and optical assemblies.
· In this position, Manufacturing Associates, will maintain manufacturing equipment, create work instructions, train others, often be asked to contribute to or lead projects, be cross functionally trained to work in several areas as needed.
· This role requires a self-starter, ability to work independently, understanding of departmental goals-working as a team to achieve those goals within set timelines. Has worked in medical device and has background testing IVD instrumentation (preferred)
· Perform Instrument Assembly in accordance with Assembly Drawings and Work Instructions.
· Carry out work in accordance with defined Quality Management System procedures and be fully supportive of Quality initiatives.
· Support general Manufacturing objectives.
· Support systems development regarding pilot instrument fabrication.
· Assist in maintaining fixtures, assembly tools, assembly instrumentation and manufacturing aids.
· Be committed to following and supporting safety practices.
· Prepares for production by reviewing work orders and production schedule, studying and clarifying specifications; calculating parts requirements; collecting materials and supplies. Set-up equipment necessary for different work orders.
· Documents production by completing applicable forms, reports, logs, and records equipment and batches using GDP practices.
· Keeps work areas clean and organized, keeping with 5S principles.
· Contributes to Continuous Improvement efforts; Identify and help implement process, procedure, safety improvements.
· Complete and maintain training records within expected timelines.
· Maintain functional understanding of cGMP’s and the impact of deviation from controlled processes and/or procedures.
· Participate in investigations as needed.
· Maintain inventory; be familiar with Kan Ban, and FIFO. May be required to complete inventory counting, kit pulling, and to handle materials.
· Completes other tasks as needed.
· High school degree plus 5 years relevant work experience; or technical associates/college degree and 2 years relevant work experience
· Experience working with optics, PCBs or other electrical/mechanical assembly preferred