Operator I
- Plymouth, MN
- Permanent
- Full-time
Shift: 1st Shift: 5:00 AM to 3:30 PM
Location: Plymouth, MNPosition Overview:The Medical Device Assembler is responsible for producing high-quality medical devices within a manufacturing cell. Under close supervision, this role performs assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related assemblies. The position requires strict adherence to procedures, documentation accuracy, and compliance with safety and quality standards.Key Responsibilities:
- Assemble, repair, and test medical devices according to standardized procedures and work instructions.
- Ensure all job documentation is accurate, up to date, and compliant with Quality Management Systems (QMS) and regulatory requirements.
- Maintain accurate production and quality records to ensure traceability of all parts.
- Communicate clearly with supervisors, managers, and team members regarding issues, ideas, and solutions.
- Follow safety guidelines and use appropriate protective equipment at all times.
- Participate in continuous improvement and Lean Manufacturing initiatives to improve production efficiency and quality.
- Support divisional initiatives, including Environmental Management Systems (EMS) and other compliance programs.
- Assist in setting and monitoring personal and team performance goals in collaboration with the Manufacturing Supervisor/Manager.
- Minimum 7th grade reading and comprehension level required.
- 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 data collection systems.
- Strong attention to detail with the ability to handle and maneuver small components and parts.
- Ability to prioritize tasks and make decisions with minimal supervision.
- Clothing must be non-shedding, clean, and free of loose fibers, frayed hems, or contamination.
- No tassels, fringes, sequins, or glitter allowed.
- All clothing from the waist up must fit under the lab coat/gown; sleeves and collars must not extend beyond gowning.
- Head coverings (bouffants, approved scarves, or wraps) must fully contain hair and fabric ends.
- Loose-fitting clothing, sweaters, fleece, or open footwear (sandals, clogs, slippers, open-toe/heel shoes) are not permitted.
- Shoes must be closed-toe, closed-heel, and flat (no heels higher than 2 inches).
- Stockings or socks are required at all times.
- Jewelry, piercings, nail polish, artificial nails, or makeup are not permitted in the production area.
- Only unscented deodorant and stick-form lip balm (applied outside production areas) are acceptable.
- Open or bleeding wounds must be covered with a bandage before entering production areas.