Manufacturing Technician Elixir Medical - 2.9 Milpitas, CA Job Details $27 - $35 an hour 19 hours ago Qualifications Computer operation Computer literacy Good documentation practices (GDP) Cleanroom protocols Factory operations documentation High school diploma or GED Manufacturing facility experience Material testing Medical device manufacturing facility experience Compliance documentation Biomedical regulatory compliance Computer skills Laboratory compliance and regulatory documentation Full Job Description Major Duties and Responsibilities Responsibilities will include, but not be limited to: Manufacture commercial, prototype, pre-clinical and clinical units in a Cleanroom Environment. Includes stent preparation, cleaning, and coating, catheter preparation and stent mounting, device inspection, and packaging Operate computer-controlled machinery Complete manufacturing documentation such as Lot History Records (LHR) in compliance with Good Documentation Practices (GDP) Perform preventive maintenance as required for production equipment Organize and assemble materials and product shipments to support commercial and development programs Inspect/test components and assemblies as part of in-process inspection Maintain work area cleanliness and compliance with various safety, fire, and hazmat guidelines Execute work in a manner compliant with FDA and ISO guidelines for medical device development and manufacture Maintain compliance with all document and procedure training requirements Qualifications Experience Minimum two years' experience as a technician in the medical device industry in a Cleanroom Environment. Experience with manufacture and mechanical testing of product Experience with GDP-compliant manufacturing documentation Ability to follow established written procedures with minimum supervision Good oral communication skills Basic computer skills Ability to lift, move and carry up to 10 lbs. Education Requirements High School diploma This position is based in Milpitas, CA and is an onsite position. The salary range of $27 to $35 per hour based on factors including experience, skills, etc.