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

SMC•Somerset, WI

2d•Onsite

About The Position

SMC Ltd. is a global healthcare contract manufacturing partner serving the Medical Device, Diagnostics, Pharmaceutical, and Drug Delivery industries. The company supports customers throughout the product lifecycle, including design and engineering, molding, fill finish, device assembly, validation, packaging and labeling, supply chain management, quality systems, and program management. The Lead Assembly monitors the work of shift employees in a medical manufacturing and assembly environment and recommends improvements to assembly methods, equipment, operating procedures, and working conditions. The role sets up and operates assembly, packaging, and test equipment according to validated processes; supports line start-up approval with Quality Technicians; trains operators; troubleshoots process and equipment issues; and works with other departments to meet product specifications and delivery schedules. The position also monitors shift performance and product quality, maintains production and scrap records and inventory, and ensures lot traceability, line clearance, and reconciliation as required. This is a second-shift position scheduled from 3:00 PM to 11:30 PM. The work takes place in a clean, climate-controlled environment, with exposure to typical machine-shop physical hazards that may require respiratory protection.

Requirements

Minimum of 3–5 years of experience in the plastics industry; assembly and clean-room/medical-device assembly experience preferred.
Ability to understand and follow company and customer quality requirements.
Knowledge and practical understanding of assembly methods and secondary-operations equipment.
Knowledge of equipment setup, operating techniques, and troubleshooting.
Ability to visualize and help design or develop tools, fixturing, and processes to maximize efficiency.
Working knowledge of ISO, FDA, GMP, and OSHA standards.
Ability to multitask and prioritize work.
Strong interpersonal and communication skills, ability to work as a team player and foster a team atmosphere, and ability to communicate with all levels of staff.
Strong technical background.
Ability to stand, walk, bend, squat, twist, reach, or otherwise move frequently; perform occasional repetitive motions and grasping; and occasionally climb to reach areas on machines or racks.
Ability to lift, move, or otherwise transfer up to 50 pounds occasionally and more than 20 pounds frequently.
Occasional computer operation involving sitting, grasping items, or keyboarding.
Ability to work around typical machine-shop physical hazards, which may require respiratory protection.

Nice To Haves

Experience in assembly and clean-room/medical-device assembly.

Responsibilities

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