Communication Skills, Computer Software, Continuous Improvement, Data Collection, Defibrillator, Documentation, English Language, Environmental Management Systems, Establish Priorities, Healthcare Quality, High School Diploma, Implants, Leadership, Lean Manufacturing, Manufacturing, Manufacturing/Industrial Processes, Medical Equipment, Pacemaker, Presentation/Verbal Skills, Product Testing, Quality Assurance, Quality Management, Regulatory Requirements, Time Management, Traceability, Writing Skills
Job Title: Operator I_MN ONLY
Work Location: Plymouth, MN
Shift: 5:00 AM to 3: 30 PM
Position Overview:
This position is responsible for the production of high-quality medical devices within a manufacturing cell. Under close supervision, the candidate will perform a combination of assembly, repair, and testing operations on products such as pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device components.
Key Responsibilities:
- Perform routine assembly, repair, and testing tasks following standardized procedures
- Ensure all production and quality documentation is accurate and up to date
- Maintain traceability of parts and complete required records for quality assurance
- Communicate effectively with team members and manufacturing leadership
- Follow all safety guidelines and use appropriate protective equipment
- Participate in continuous improvement and quality initiatives (Lean Manufacturing environment)
- Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements
- Prioritize tasks based on production needs and deadlines
- Handle and maneuver small components with precision
- Utilize electronic data collection systems and basic computer software
Required Skills & Qualifications:
- Good hand-eye coordination and fine motor skills
- Strong communication skills (written and verbal)
- Willingness to learn new processes and follow instructions
- Ability to read and comprehend procedures (minimum 7th-grade English level)
- Ability to work under close supervision and follow detailed instructions
- Basic understanding of manufacturing processes (Lean knowledge is a plus)
- High School Diploma or equivalent preferred
Preferred Experience:
- Prior experience in medical device manufacturing or similar industry (preferred but not required)
- Microscope experience is a plus (training provided if needed)
Work Environment & Physical Requirements:
- Primarily seated role (approximately 95% sitting)
- No lifting requirements
- Ability to handle small parts and perform repetitive tasks
Dress Code Requirements (Strict Compliance Required):
- Non-shedding, clean clothing free of loose fibers, frays, or contaminants
- No loose-knit garments, fleece, sweaters, or exposed fibers
- Clothing must fully fit under lab gown; no exposed sleeves or high-neck garments
- Closed-toe, closed-heel shoes required (heels must be under 2 inches)
- No sandals, clogs, slippers, or open footwear
- Hair coverings must comply with gowning standards
- No jewelry, piercings, nail polish, artificial nails, or makeup allowed
- No scented personal products (except deodorant)
- All skin must be appropriately covered (no shorts, sleeveless tops, or above-ankle garments)
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Axelon Services Corporation