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 highprecision metal machining, finishing, assembly, and anodizingyour expertise ensures those processes run safely, repeatably, and costeffectively at mid to high volumes.
A week in the role
- Walk the floor to eliminate downtime, scrap, and tooling issues; launch quick containment and durable countermeasures when defects surface.
- Optimize tooling through toollife studies and process capability analyses to improve throughput and reduce cost.
- Lead production transfers and rampups, 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.
What you bring
- 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.
- Handson experience with lean methods and Kaizen (participant and/or facilitator).
- Thrives in a fastpaced medical device manufacturing setting with high output and uncompromising quality.
Education
- Bachelor’s degree in an engineering discipline, or equivalent experience.
Experience
- 5+ years in a regulated industry; medical device or aerospace contract manufacturing preferred.
Preferred skills
- Strong time management and prioritization across competing demands.
- Selfstarter who succeeds independently and in crossfunctional teams.
- Clear, concise communicator in written and spoken English.
Physical requirements
- 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.
