Role: Operator I
Location: Minnetonka, MN - 55345
Job Description:
This role requires at least a 7th-grade level of reading and comprehension.
The position involves manufacturing high-quality medical devices within a controlled production environment. Under close supervision, the individual will perform tasks such as assembly, repair, and testing of devices including pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related components. Work is completed following standardized procedures and is regularly reviewed.
Key Responsibilities:
- Perform routine assembly, testing, and repair tasks
- Maintain accurate documentation and ensure traceability of all parts
- Follow all safety protocols and use appropriate protective equipment
- Communicate effectively with team members and management
- Support quality and continuous improvement initiatives
- Assist in meeting production and performance goals
- Ensure compliance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory standards
Basic Requirements:
- High school diploma or equivalent
- Ability to read and follow written and verbal instructions
- Basic computer skills and familiarity with data systems
- Strong attention to detail and ability to prioritize tasks
- Ability to handle small components and make decisions with minimal supervision
- Basic understanding of Lean Manufacturing principles
Work Environment & Dress Code:
- Must wear clean, non-shedding clothing free of loose fibers or contamination
- Clothing must fully cover the body and fit under lab gowns
- No loose garments, exposed skin, or prohibited fabrics (e.g., fleece, frayed materials)
- Closed-toe, low-heel shoes are required (no sandals or open footwear)
- No jewelry, makeup, nail polish, or scented products (except deodorant)
- Hair coverings must comply with hygiene standards
- Follow strict cleanliness and safety guidelines at all times