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Manufacturing / Production
Manufacturing Engineer, Quality Engineering, Manufacturing & Industrial Operations, Medical Device Industry
Job Description & How to Apply Below
Location: Town of Somerset
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.
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.
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.
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.
- Clean, Climate-Controlled Environment
- Stable schedule
- Paid holiday and PTO
- Health, dental, and vision insurance
- 401(k) retirement savings
- Life and disability insurance
- Promotio…
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