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.