Senior Medical Device Assembly Lead, 2nd Shift

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

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.