Manufacturing Technician

Elixir Medical Corporation; Milpitas (CA); On-site; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a dedicated Manufacturing Technician to join their team in a Cleanroom Environment. In this role, you will be responsible for manufacturing medical devices, ensuring compliance with FDA and ISO guidelines, and maintaining high standards of cleanliness and safety. The ideal candidate will have at least two years of experience in the medical device industry, showcasing strong skills in manufacturing documentation and mechanical testing. This is an exciting opportunity to contribute to innovative medical solutions while working in a collaborative and supportive environment.

Benefits

Medical insurance

Vision insurance

401(k)

Disability insurance

Qualifications

• Minimum two years' experience in the medical device industry.
• Experience with manufacture and mechanical testing of products.

Responsibilities

• Manufacture medical devices in a Cleanroom Environment.
• Operate computer-controlled machinery and maintain documentation.

Skills

Manufacturing documentation

Good Documentation Practices (GDP)

Mechanical testing

Oral communication

Basic computer skills

Job description

Elixir Medical Corporation provided pay range

This range is provided by Elixir Medical Corporation. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$27.00/hr - $35.00/hr

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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing

• Industries

  Medical Device

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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