The Assembly Tech I will perform assembly processes on a variety of complex electro-mechanical and optically based sub-assemblies and finished medical devices while following Current Good Manufacturing Practices (cGMP). The Assembly Tech I 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.
- Assemble subassemblies and final assemblies per written specifications i.e., work instructions, customer drawings, etc.
- Complete manufacturing documentation as outlined in the work order package and defined by the customer.
- Package final product per written specifications.
- Identify and report any product quality problems or discrepancies.
- Document non-conformances.
- 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.
- Positive attitude, self motivator.
- Superior customer service attitude.
- Excellent teamwork and communication skills.
- High School Diploma or equivalent.
- Experience in medical device manufacturing preferred.
- Experience in basic manufacturing methods.
- 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
- Electro-mechanical assembly
- Opto-mechanical assembly
- Use of epoxy and dispensing tools
- Use of torque tools
- Tubing heat shrink
- ESD precautions/practices
Cogmedix, located in West Boylston, MA, is an FDA registered, ISO 13485 certified company that provides turnkey medical device engineering and manufacturing services to medical and dental OEMs through its Medical Technology Brought to Life™ mission. Cogmedix delivers high-quality finished devices to market with compliance, competence, and commitment. Cogmedix is a subsidiary of Coghlin Companies, Inc., a privately held Time to Market Services™ Company.