Manufacturing Operator

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

• High School diploma
• 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.