Production Operator - Medical Device Assembly (on-site)

KEY DUTIES AND RESPONSIBILITIES

• Working with the Operations and Quality organizations, under direct supervision, in the production of Human-Use products. 
• Performing assembly of products using small parts and equipment such as, not limited to: microscopes, small tools, ovens, cleaning equipment and fixturing with well-defined documentation in a controlled environment-area. 
• Maintaining a clean and well organized work area. 
• Following standard operating procedures (SOPs), instructions and manufacturing processes in compliance with company and regulatory guidelines. 
• Completing detailed production traceability documentation while ensuring understanding and utilization of QAD for activities as required. 
• Performing inventory management activities in production, as required. 
• Providing feedback to engineering on build, process, tooling and yield issues in production. 
• Performing other production and/or assembly tasks as assigned.

REQUIRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE

• High School diploma or equivalent is required (minimum)
• Proficiency in reading and writing English
• High attention to detail and ability to be accurate in documentation is a must
• Self-motivated, a quick learner
• Ability to work independently and cooperatively in a team environment
• Dedicated to maintaining product quality by following established procedures 
• Capable of understanding and interfacing with shop-floor software programs

PREFERRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE

• 1-2 years of experience with assembly of products in a clean room (CAE) production environment 
• 1-2 years of assembly experience in a medical device manufacturing environment
• Experience in assembly of implantable medical devices (Class III) in a clean room (CAE) environment. 

WORKING CONDITIONS

• 8 hour workdays from 7:00 - 3:30 PM Central Time 
• Controlled Access Environment (CAD) working conditions; including gowning, wearing of hairnets, gloves, special footwear and cleanroom smock)
• Occasionally scheduled overtime may be required
• Capable of lifting 20 pounds
• Manual assembly using small tools and microscopes