Cleanroom, Communication Skills, Computer Skills, Computer Software, Continuous Improvement, Data Collection, Defibrillator, Detail Oriented, Documentation, Environmental Management Systems, Establish Priorities, Healthcare Quality, High School Diploma, Implants, Lean Manufacturing, Maintain Compliance, Manicures, Manual Dexterity, Manufacturing, Manufacturing Operations Management, Medical Equipment, Medical Tests, Medical Treatment, Organizational Skills, Pacemaker, Production Support, Quality Assurance, Quality Management, Regulations, Safety/Work Safety, Support Documentation, Testing, Traceability
Job Title: Operator I
Location: Minnetonka, MN
Shift Hours: 3:30 PM to 2:00 AM
Job Description
This position is responsible for the production of high-quality medical devices within a manufacturing cell environment. Under close supervision, candidates may perform a combination of assembly, repair, inspection, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device components.
Responsibilities include following standardized procedures, maintaining accurate production documentation, and supporting quality and safety initiatives in a regulated manufacturing environment.
Key Responsibilities
- Assemble, repair, inspect, and test medical device components according to established procedures and specifications
- Perform routine manufacturing operations under close supervision
- Maintain accurate production, traveler, and quality documentation to ensure traceability
- Follow all safety procedures and use appropriate protective equipment
- Support Lean Manufacturing and continuous improvement initiatives
- Communicate effectively with manufacturing team members and management
- Utilize electronic data collection systems and basic computer software
- Prioritize tasks and manage workflow efficiently
- Ensure compliance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory standards
- Maintain a clean and organized work environment
Qualifications
- High school diploma or equivalent preferred
- Ability to read, comprehend, and follow written procedures and verbal instructions
- Basic computer skills and ability to use electronic systems
- Strong attention to detail and manual dexterity
- Ability to handle small components and parts
- Ability to make sound decisions with minimal supervision
- Must maintain a positive and professional attitude in a team environment
Additional Requirements
- These positions require a 7th grade reading and comprehension level
- Candidates must be able to work in a cleanroom/manufacturing environment and follow strict gowning and contamination-control requirements
Dress Code Requirements (Interview Tour & Production Floor)
To maintain cleanroom standards and safety compliance, the following are required:
- Clothing must be clean, non-shedding, and free of loose fibers, glitter, sequins, tassels, or frayed material
- Sweaters, fleece, loose-knit garments, and loose-fitting clothing are not permitted
- All clothing must fit under lab coats/gowns
- Closed-toe and closed-heel shoes are required; heels must not exceed 2 inches
- Sandals, clogs, slippers, and open-weave shoes are prohibited
- Pants, sleeves, and tops must fully cover legs, torso, and upper arms
- Nail polish, acrylic nails, artificial nails, makeup, perfumes, and scented products are not allowed
- Jewelry or piercings that cannot be covered or may damage gloves are prohibited
- Hair coverings must comply with gowning requirements
- Any cuts or wounds must be fully covered with bandages
- Clothing or accessories that may be offensive are not permitted
A
Axelon Services Corporation