Operator I_MN ONLY

Job Title: Operator I
Shift: 1st Shift | 5:00 AM 3:30 PM
Location: Plymouth, MN (Onsite)

Job Description

The Operator I is responsible for producing high-quality medical devices within a manufacturing cell. Under close supervision, the operator performs routine assembly, repair, and testing of pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device components in accordance with standardized procedures. All work is closely reviewed to ensure quality and compliance.

Responsibilities

• Assemble, repair, and test medical device components per established procedures

• Perform routine manufacturing tasks in a regulated environment

• Maintain accurate job documentation, travelers, and quality records

• Ensure part traceability and support quality issue resolution

• Follow safety procedures and use required safety equipment

• Communicate effectively with manufacturing leadership and team members

• Maintain a professional and positive attitude during internal and external interactions (including tours)

• Participate in continuous improvement and quality initiatives

• Demonstrate basic knowledge of Lean Manufacturing principles

• Support individual and cell performance goals

• Comply with Quality Management System (QMS), Environmental Management System (EMS), and regulatory requirements

Required Skills

• Ability to read, understand, and follow written and verbal instructions

• Experience using electronic data collection systems and basic computer software

• Strong attention to detail and documentation accuracy

• Ability to prioritize work based on production needs

• Manual dexterity to handle small components

• Ability to make decisions with minimal supervision

Education

• High school diploma or equivalent preferred

Physical & Work Environment Requirements

• Ability to handle small parts and components

• Ability to work in a manufacturing/cleanroom environment

• Compliance with strict gowning and safety standards

Dress Code Requirements (Interview & On-the-Job)

• Non-shedding, tightly woven clothing only

• No loose fibers, frayed hems, glitter, sequins, or decorative items

• No sweaters, fleece, loose knits, or fiber-shedding garments

• Clothing must fit completely under lab coat/gown

• Closed-toe, closed-heel shoes required (heel d 2 inches)

• No sandals, open-toe/open-heel shoes, clogs, or woven/strapped shoes

• Socks or stockings required

• No nail polish, artificial nails, makeup, jewelry, or uncovered piercings

• No scented products except deodorant

• Lip balm (stick form only) allowed outside production areas

• Head coverings must be fully covered by bouffant and gown

• All wounds must be properly bandaged

• No offensive attire permitted