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Production Lead

Axelon Services Corporation
Minnetonka, MN Contractor
POSTED ON 5/3/2025
AVAILABLE BEFORE 6/1/2025
Job Title: Production Lead
Location: Minnetonka, MN
Schedule: 5am - 3:30pm, Mon - Thurs
Duration: 1 year contract with potential for extension or conversion based on performance and business needs
Position Summary:

We are seeking a proactive and experienced Group Lead to oversee 20–25 operators on a production line in a cleanroom environment. This individual will support daily production activities, ensure SOP compliance, coordinate training, and work closely with supervisors to monitor performance and resolve production challenges. Experience in medical device manufacturing and working knowledge of Windchill is highly preferred.

Key Responsibilities:
  • Lead and coordinate production activity in assigned work areas to align with build schedules.

  • Deliver clear work instructions and ensure compliance with SOPs and quality standards.

  • Conduct regular process and quality audits of personnel, equipment, and tooling.

  • Escalate issues related to machine performance, product quality, or staffing as needed.

  • Train new operators and provide ongoing support, re-training, and feedback.

  • Assist in staging production paperwork, managing work-in-process inventory, and tracking daily outputs.

  • Support documentation updates using Windchill and assist in printing and staging line paperwork.

  • Perform direct manufacturing tasks when necessary to support production needs.

  • Conduct 5S audits and collaborate in weekly cross-functional meetings for continuous improvement.

  • Ensure PM and calibration compliance for equipment and tools.

  • Maintain accurate records, participate in BBSP observations, and support QMS/EMS initiatives.

  • Support regulatory compliance including FDA and other governing agencies.

  • Provide assistance with employee needs, including training and system support.

Required Qualifications:
  • High school diploma or GED required.

  • Minimum 2 years of experience as a group leader or team lead in a production/manufacturing setting.

  • Demonstrated experience leading a team of 20 operators.

  • Strong communication skills and ability to deliver clear instructions and feedback.

  • Ability to work in a regulated cleanroom environment.

  • Proficient in MS Office; basic production paperwork and documentation handling.

Preferred Qualifications:
  • Medical device manufacturing experience strongly preferred.

  • Experience using Windchill for document control and updates.

  • Understanding of FDA regulations and quality systems (QMS).

  • Familiarity with preventive maintenance (PM) processes and 5S principles.

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