Lead Assembly | 2nd Shift| 3:00PM-11:30PM

SMC Ltd; Somerset (KY); On-site; USD 48,000 - 72,000; 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. is seeking a Lead Assembly on the 2nd shift to monitor and guide a medical device assembly team in a climate-controlled production environment. You will set up, operate, and troubleshoot assembly lines, ensuring adherence to validated processes and quality standards.

Ideal candidates bring 3–5 years of plastics/medical device assembly experience, knowledge of ISO/FDA/GMP/OSHA standards, and strong interpersonal skills to lead a team toward on-time delivery and continuous improvement.

Qualifications

• Minimum of 3–5 years of experience in the plastics industry, preferably assembly, and clean room/medical device assembly.
• Ability to understand and practice company and customer quality requirements.
• Knowledge and practical understanding of various assembly methods and secondary operations equipment.
• Knowledge of equipment setup, operating techniques, and troubleshooting.
• The ability to visualize and help design/develop tools, fixturing, and processes to obtain maximum efficiency.
• Working knowledge of ISO, FDA, GMP, and OSHA standards.
• Ability to multi-task and prioritize work.
• Strong interpersonal and communication skills; be a team player; and have the ability to develop a team atmosphere.

Responsibilities

• Set up and operate Assembly, Packaging, and Test equipment, per validated processes, to produce medical devices or sub-assemblies. Work with Quality Technician for start-up approval of assembly lines.
• Monitor and provide ongoing feedback regarding the daily performance of shift employees and help to ensure product conformance to customer specifications and scheduled delivery dates, while helping to monitor the quality, assembly, scrap, safety, cost and customer service for the shift.
• Train operators in proper work methods per specifications and work instructions
• Set up, troubleshoot, and resolve process/equipment problems. Monitor processes, policies and procedures and recommend improvements in assembly methods, equipment, operating procedures, working conditions (safety, quality, productivity, and cost) and cost effectiveness.
• Work closely with customer service, quality, scheduling and various other departments to ensure assembly and quality of products meet specifications and delivery times.
• Post daily assembly, daily scrap, and monitor inventory of product used.
• Maintain lot traceability and perform line clearance and reconciliation, as required.
• Perform other duties as required.

Skills

Interpersonal skills

Communication

Teamwork

Job description

Lead Assembly | 2nd Shift| 3:00PM-11:30PM

Somerset, WI, US

About Us:

SMC Ltd. is a global healthcare contract manufacturing partner serving the Medical Device, Diagnostics, Pharmaceutical, and Drug Delivery industries. With manufacturing locations across the United States, Costa Rica, India, and the United Kingdom, we help customers bring breakthrough healthcare products to market and scale them for commercial success.

Our expertise spans the entire product lifecycle, including design and engineering, thermoplastic and medical micro molding, liquid silicone injection molding (LIM), fill finish, combination devices, complete device assembly, validation, packaging and labeling, supply chain management, quality systems, and program management.

What sets SMC apart is our ability to combine world-class manufacturing capabilities with responsive, hands-on partnerships. Our teams work directly with customers to solve complex challenges, accelerate innovation, and deliver life-changing healthcare solutions to patients around the world.

Job Summary: Monitor work of shift employees in a medical manufacturing and assembly environment: recommend improvements in assembly methods, equipment, operating procedures and working conditions.

Essential Job Duties and Responsibilities:

• Set up and operate Assembly, Packaging, and Test equipment, per validated processes, to produce medical devices or sub-assemblies. Work with Quality Technician for start-up approval of assembly lines.
• Monitor and provide ongoing feedback regarding the daily performance of shift employees and help to ensure product conformance to customer specifications and scheduled delivery dates, while helping to monitor the quality, assembly, scrap, safety, cost and customer service for the shift.
• Train operators in proper work methods per specifications and work instructions
• Set up, troubleshoot, and resolve process/equipment problems. Monitor processes, policies and procedures and recommend improvements in assembly methods, equipment, operating procedures, working conditions (safety, quality, productivity, and cost) and cost effectiveness.
• Work closely with customer service, quality, scheduling and various other departments to ensure assembly and quality of products meet specifications and delivery times.
• Post daily assembly, daily scrap, and monitor inventory of product used.
• Maintain lot traceability and perform line clearance and reconciliation, as required.
• Perform other duties as required.

Essential Qualifications:

• Minimum of 3 – 5 years of experience in the plastics industry, preferably assembly, and clean room/medical device assembly.
• Ability to understand and practice company and customer quality requirements.
• Knowledge and practical understanding of various assembly methods and secondary operations equipment. Knowledge of equipment setup, operating techniques, and troubleshooting.
• The ability to visualize and help design/develop tools, fixturing, and processes to obtain maximum efficiency.
• Working knowledge of ISO, FDA, GMP, and OSHA standards.
• Ability to multi-task and prioritize work.
• Strong interpersonal and communication skills; be a team player; and have the ability to develop a team atmosphere. Must be able to communicate with all levels of staff.
• Strong technical background.

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

ADA Requirements:

• Stand, walk, bend, squat, twist, reach or otherwise move frequently
• Occasional repetitive motion and grasping
• Occasional climbing to reach areas on machines or racks
• Lift, move or otherwise transfer up to 50 lbs. occasionally, >20 lbs. frequently
• Typically sits, grasps items or performs keyboarding for occasional operation of a computer
• Exposure to typical machine shop physical hazards which may require respiratory protection

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.