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 TOMZwhere 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 transferspartnering 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 productstargeting 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 backgroundparticipation 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 Englishboth 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.
