Manufacturing Technician

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 production technician to manufacture medical devices across commercial, prototype, pre-clinical and clinical units in a cleanroom environment. You will mount, assemble and inspect components, operate computer-controlled machinery, and ensure documentation meets GDP standards.

The role requires at least two years of cleanroom experience in the medical device industry, the ability to follow established procedures with minimal supervision,

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 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 safety, 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

Cleanroom experience

GDP documentation

Mechanical testing

Good communication

Basic computer skills

Lifting up to 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.