Senior Lead

SMC Ltd; Somerset (KY); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Clean, Climate-Controlled Environment

Paid holiday and PTO

Health, dental, and vision insurance

401(k) retirement savings

Life and disability insurance

Promotional opportunities

Training and career growth programs

Employee Assistance Program

Job summary

SMC Ltd. in Somerset, KY, is seeking a Focus Factory Senior Lead to oversee daily operations in injection molding and assembly of medical device components. You will coordinate operators, enforce GMP, and drive continuous improvement in a clean, compliant manufacturing environment.

The role requires 1–2 years in manufacturing leadership, strong communication, and familiarity with ISO 13485 and 21 CFR 820. You will train staff, monitor metrics, and support lean initiatives while maintaining

Qualifications

• 1-2 years of experience in a manufacturing environment in a lead role or equivalent education.
• 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.

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).
• 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.

Job description

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

Job Summary:

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.

Essential Job Duties and 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).
• 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.

Essential Qualifications:

• 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.

Desirable Qualifications:

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

ADA Requirements:

• Typically sits, grasps items and performs keyboarding for frequent operation of a computer
• Stand, walk, bend, reach or otherwise move about occasionally
• Lift, move or otherwise transfer items up to 50 lbs. occasionally
• Exposure to typical machine shop physical hazards which may require respiratory protection

ADA Requirements:

• Typically sits, grasps items and performs keyboarding for operation of a computer.
• Stand, walk, bend, reach or otherwise move about occasionally.
• Lift, move, or otherwise transfer items up to 30 lbs. occasionally.
• Occasional exposure to typical manufacturing physical hazards.
• Travel by air or car occasionally

What SMC has to offer?

• Clean, Climate-Controlled Environment
• Paid holiday and PTO
• Health, dental, and vision insurance
• 401(k) retirement savings
• Life and disability insurance
• Promotional opportunities
• Training and career growth programs
• Employee Assistance Program

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.