Precision Manufacturing Process Engineer -- Medical Devices

Job Description

Job Description

Shape scalable, compliant manufacturing in Berlin, CT

Reporting to the Engineering Manager, you will be the go-to engineer who transforms concepts into stable, efficient production for TOMZ’s medical device components. Our products are built through high‑precision metal machining, finishing, assembly, and anodizing—your expertise ensures those processes run safely, repeatably, and cost‑effectively at mid to high volumes.

• Walk the floor to eliminate downtime, scrap, and tooling issues; launch quick containment and durable countermeasures when defects surface.
• Optimize tooling through tool‑life studies and process capability analyses to improve throughput and reduce cost.
• Lead production transfers and ramp‑ups, standing up robust processes ready for volume manufacturing.
• Author and refine clear work instructions, flow, layout, and controls that elevate quality, safety, and efficiency.
• Own risk management activities (e.g., PFMEA), equipment qualification, and process validations (IQ, OQ, PQ).
• Drive engineering change orders (ECOs), coordinate deployment, and train Operations to ensure smooth adoption.
• Design/qualify tools and equipment that enable reliable manufacturing performance.
• Facilitate Kaizen events and continuous improvement initiatives to remove waste and standardize best practices.
• Train Engineering and Operations personnel on processes and equipment; disposition nonconforming material and create effective rework procedures.
• Adhere to the TOMZ Quality Management System and perform other duties as assigned.

• Meticulous attention to detail and a bias for practical problem solving.
• Ability to interpret drawings and specifications with GD&T.
• SolidWorks proficiency.
• Comfort with Microsoft Office and Adobe tools.
• Working knowledge of GMP and ISO 13485 requirements.
• Hands‑on experience with lean methods and Kaizen (participant and/or facilitator).
• Thrives in a fast‑paced medical device manufacturing setting with high output and uncompromising quality.

• Bachelor’s degree in an engineering discipline, or equivalent experience.

• 5+ years in a regulated industry; medical device or aerospace contract manufacturing preferred.

• Strong time management and prioritization across competing demands.
• Self‑starter who succeeds independently and in cross‑functional teams.
• Clear, concise communicator in written and spoken English.

• Able to bend, stoop, squat, kneel, and lift up to 20 pounds; use team lift or mechanical assist for heavier items.
• 20/20 vision (assisted or unassisted) for sorting raw and nonconforming materials; good dexterity for small to medium products.
• Comfort with shop exposure (oil, grease, dust, metal particles, sparks, sharp edges); PPE or engineering controls may be required.
• Regular keyboard input and frequent computer use.