Operator/ Machine Operator/ Assembler/ Cleanroom/ Production Worker

The role requires strong attention to detail, the ability to follow written and verbal instructions, safe handling of small components, accurate documentation, and adherence to quality and regulatory requirements. Required Qualifications Ability to read, comprehend, and follow written procedures at approximately a 7th-grade reading and comprehension level .

Operator I| Minnetonka, MinnesotaWork Schedule:

• Start Time: Approximately 4:45 AM 5:00 AM
• End Time: Approximately 3:15 PM 3:30 PM

Job Summary:
The Operator I performs routine and repetitive assembly operations under direct supervision in a regulated medical device manufacturing environment. The role requires strong attention to detail, the ability to follow written and verbal instructions, safe handling of small components, accurate documentation, and adherence to quality and regulatory requirements. Key Responsibilities:

• Perform routine and repetitive assembly operations according to established procedures and work instructions.
• Read, understand, and follow written procedures and verbal instructions.
• Ensure job documentation for cell operations is accurate and up to date.
• Handle, maneuver, and assemble small components and parts accurately.
• Maintain accurate traveler, production, and quality documentation.
• Ensure all parts and materials are properly traceable.
• Identify and communicate quality issues, production concerns, and potential problems.
• Perform basic troubleshooting of equipment and assembly processes.
• Perform routine and preventive maintenance on applicable equipment and tools.
• Follow all safety guidelines and properly use required safety devices and PPE.
• Participate in continuous improvement and quality initiatives.
• Support Lean Manufacturing and continuous improvement activities.
• Work with supervisors and managers to monitor individual and cell performance metrics.
• Prioritize work based on job requirements, sequence, timing, and importance.
• Communicate ideas, problems, and solutions effectively to manufacturing management.
• Demonstrate teamwork, cooperation, flexibility, active listening, and conflict-resolution skills.
• Maintain a positive and professional attitude with internal and external customers.
• Represent the company professionally during facility tours by demonstrating appropriate techniques and sharing relevant information.
• Support company policies, procedures, Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
• Support divisional initiatives and manufacturing goals related to quality, safety, productivity, and profitability.

Required Qualifications

• Ability to read, comprehend, and follow written procedures at approximately a 7th-grade reading and comprehension level.
• Ability to understand and follow verbal instructions.
• Basic computer skills and ability to use electronic data collection systems.
• Ability to use computer software and manufacturing systems.
• Strong attention to detail and ability to maintain accurate records.
• Ability to prioritize multiple tasks based on urgency and importance.
• Ability to handle and maneuver small components and parts.
• Ability to make decisions and exercise judgment with minimal supervision.
• Strong communication and interpersonal skills.
• Ability to work effectively in a self-managed or team-based manufacturing environment.

Preferred Qualifications

• 6+ months of experience in medical, manufacturing, production, assembly, or another regulated environment.
• Previous medical device manufacturing experience preferred.
• Previous assembly or production experience preferred.
• High school diploma or equivalent preferred.