Manufacturing Operator

Elixir Medical Corporation; Milpitas (CA); On-site; USD 37,000 - 48,000; Full time

Job summary

Elixir Medical Corporation in Milpitas, CA, is seeking a manufacturing technician to produce commercial, prototype, pre-clinical and clinical units in a cleanroom environment. You will perform stent preparation, catheter handling, mounting, device inspection and packaging, while maintaining GDP-compliant documentation.

You will operate computer-controlled machinery, perform preventive maintenance, and ensure safety and regulatory compliance for FDA/ISO guidelines throughout the manufacturing

Qualifications

• 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.

Responsibilities

• 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

Skills

Good oral communication

Basic computer skills

Lift 10 lbs

Job description

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

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.