Senior Lead

SMC Ltd.•Somerset, WI

10d•Onsite

About The Position

The Focus Factory Senior Lead oversees daily operations supporting the injection molding and assembly of medical device components. This entry-level leadership role ensures that production activities meet stringent cleanliness, quality, and regulatory requirements. The senior lead coordinates operator activities, enforcing protocols, and supports continuous improvement while maintaining a safe, compliant, and efficient manufacturing environment.

Requirements

1-2 years of experience in a manufacturing environment in a lead role or equivalent education considered.
Basic understanding of injection molding, cleanroom operations, and regulated manufacturing environments.
Strong communication skills with the ability to lead, coach, and motivate entry-level operators.
Ability to read and interpret work instructions, quality documents, and basic technical drawings.
Comfortable using ERP systems, production software, and standard Microsoft Office tools.
Detail oriented with strong organizational and problem-solving abilities.

Nice To Haves

1–3 years of experience in manufacturing; cleanroom or medical device experience strongly preferred.

Responsibilities

Assist in cleanroom gowning procedures, contamination control practices, and environmental monitoring requirements as applicable.
Ensure all personnel follow ISO 13485, FDA 21 CFR Part 820, and internal quality system standards as needed.
Maintain cleanroom discipline, including material flow, personnel movement, and adherence to housekeeping standards (5S) as needed.
Support cleanroom molding and assembly utilization: post mold processes: automation cells, ultrasonic welding, pad printing, bonding, and manual assembly as needed.
Ensure lot traceability, device history records (DHR), and cleanroom logs are completed correctly.
Identify opportunities to improve cleanroom efficiency, ergonomics, and process consistency.
Provide support to operators running injection molding presses, automated molding cells, and secondary operations.
Monitor molding machine status, automation cells, secondary equipment, material changes, and basic troubleshooting (short shots, flash, gate issues).
Coordinate with process technicians and engineering on mold setups, process deviations, and equipment concerns.
Assign daily tasks and ensure production goals are met.
Train employees on work instructions, cleanroom behavior, and Good Manufacturing Practices (GMP).
Conduct accurate shift start-ups, end‑of‑shift reporting, and effective handoff communication.
Track daily production metrics including scrap, downtime, yield, and throughput.
Escalate nonconformances and assist with corrective/preventive actions.
Promote a safe work environment by enforcing safety policies and participating in incident investigations.
Support lean initiatives such as 5S, waste reduction, and workflow optimization.
Adhere to operations schedule with other supervisors, schedulers and production managers.
Support in issuing disciplinary warnings with assistance from the Focus Factory Manager and/or Human Resources.