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Engineering
Manufacturing / Production Technician
Berlin, CT
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Now viewing: NPI Manufacturing Engineer — MedTech Precision Machining
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TOMZ Manufacturing Corp

NPI Manufacturing Engineer — MedTech Precision Machining

Job Description

Location:
Berlin, CT Reports to: Engineering Manager A day in this role When the lights come on in our Berlin, CT facility, you're already mapping the day: confirming tooling availability, lining up a new product transfer, and reviewing overnight production data. By mid-morning, you're on the floor partnering with machinists to eliminate a recurring downtime issue. After lunch, you finalize an engineering change order, brief Operations on updated work instructions, and prep for an
IQ/OQ/PQ
validation run on a new anodize process. You wrap the day by updating PFMEA actions and scheduling a Kaizen focused on cycle-time reduction. That's a snapshot of life as an NPI Manufacturing Engineer at TOMZ—where precision CNC machining, finishing, assembly, and anodize processes come together to build critical medical device components. What you'll do Design and implement robust, cost-efficient manufacturing methods that scale from pilot to mid/high-volume production. Lead production transfers—partnering with cross-functional teams to stand up stable processes for volume launch. Reduce equipment/tooling downtime and scrap; perform tool-life studies to drive throughput and cost savings. Run manufacturing process capability studies and act on findings to meet quality and delivery objectives. Continuously improve processes, controls, and methods for sustained and new products—targeting quality, cost, and efficiency. Create and execute engineering change orders; coordinate deployment and train Operations on updates. Author and refine manufacturing instructions, product flows, assembly methods, space utilization, and safety practices. Develop, qualify, and deploy production tooling and equipment necessary for CNC machining, finishing, assembly, and anodize. Analyze product and process performance to identify cost reduction and quality improvement opportunities. Apply risk tools such as PFMEA to reveal potential failure modes and define corrective/preventive actions. Support and execute equipment qualifications and process validations, including IQ, OQ, and PQ. Troubleshoot defects, lead root-cause investigations, and implement immediate containment and durable countermeasures. Train Engineering and Operations personnel on processes and equipment as needed. Disposition nonconforming material and create safe, effective rework procedures. Plan and facilitate Kaizen events; champion Lean and continuous improvement throughout the value stream. Work in accordance with the TOMZ Quality Management System and perform other duties as assigned. What you'll bring Meticulous attention to detail and a bias for action in a fast-paced medical device manufacturing environment. Fluency in reading drawings and specifications with GD&T. Proficiency in SolidWorks, plus practical experience with Microsoft Office and Adobe tools. Working knowledge of GMP and
ISO 13485
requirements. Hands-on continuous improvement background—participation in and/or facilitation of Kaizen using Lean principles. Education & Experience Bachelor's degree in an engineering discipline or equivalent experience. 5+ years in a regulated industry, preferably with a medical device or aerospace contract manufacturer. Preferred skills Excellent time management and the ability to prioritize shifting workloads. Self-starter who thrives independently and collaborates effectively. Clear, confident communication in English—both written and verbal. Physical requirements Able to bend, stoop, squat, kneel, and lift up to 20 pounds; team lift or mechanical assist for heavier objects. 20/20 vision (assisted or unassisted) for sorting raw and non-conforming materials; strong manual dexterity for small to medium parts. Comfort with exposure to oil, grease, dust, metal particles, sparks, and sharp-edged materials; PPE or engineering controls may be required. Frequent computer use and data entry.

Benefits

  • Dental Insurance
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