Assembly Tech III
Cogmedix
Job Description
Job Description
The Assembly Tech III will perform assembly processes on a variety of significantly complex electro-mechanical and optically based sub-assemblies and finished medical devices while following Current Good Manufacturing Practices (cGMP). The Assembly Tech II will use a variety of tools and adhere to proper released build instructions and Quality System procedures, proper material handling, ESD procedures, and more. All Assembly Technicians are also responsible for following good documentation practices (GDP) and performing all required electronic systems transactions accurately and in real time. The Assembly Tech III may participate in a Scaled Product Launch™ Team, work directly with customers, and may train other assembly technicians.
- Responsibilities:
- Assembles significantly complex subassemblies and final assemblies per written specifications and/or drawings.
- May transition between multiple product lines within a short period of time.
- Participates in Scaled Product Launch™ Teams as required.
- Performs training to other assembly technicians as required.
- Completes manufacturing documentation as outlined in the work order / Device History Record package.
- Performs all transactions in Cogmedix electronic business systems accurately in real time, and understands cause and effect of the transactions.
- Packages final product per written specifications.
- Communicate to QE, ME and required Operations Management any product quality problems or discrepancies and assist will finding resolution.
- Documents non-conformances.
- Conduct final assembly, system functionality testing, electrical safety testing and final calibration.
- Integrate sub-assemblies, electrical panels, chassis, power supplies and connecting cables.
- Inspect and calibrate final products as needed.
- Perform processes utilizing tools such as calipers, micrometers and multimeters.
- Strong ability to assemble, disassemble and repair.
- Responsible for following cGMP and ISO 13485 requirements.
- Maintain the work area and equipment in a clean and orderly condition and follow prescribed safety regulations.
- Maintain proper control of device traceability materials and non-conforming material.
- Other duties as required.
- Essential Requirements:
- Positive attitude, self-motivator, ability to work unsupervised.
- Superior customer (internal and external) service attitude.
- Excellent teamwork and communication skills.
- High School Diploma or equivalent. Certain work experience may be considered in lieu of educational requirements.
- Experience in medical device manufacturing preferred.
- Experience in complex manufacturing using advanced methods required.
- Experience in electro-mechanical and opto-mechanical assembly required.
- Experience using torque tools, epoxy, epoxy dispensing tools, tubing heat shrink required.
- Flexibility to multi-task across several product lines in a short period of time required.
- Must be able to read, write, and comprehend detailed manufacturing procedures and drawings in English.
- A demonstrated commitment to company values.
- Excellent manual dexterity and eye/hand coordination.
- Ability to climb stairs.
- Standing for prolonged periods of time.
- Sitting for prolonged periods of time.
- Ability to lift up to 30 lbs.
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