Industrialization & NPI Engineer Lean Medical Device Operations
Worksite: Berlin, CT
Make an impact
Every micron matters when the end user is a patient. At TOMZ, you will transform designs into stable, scalable manufacturing processes across high-precision machining, finishing, assembly, and anodizedriving quality, speed, and cost efficiency for medical devices.
Imagine this scenario
An urgent product transfer is on the horizon. You lead a cross-functional team to map product flow, design tooling, and establish controls. You execute PFMEA to anticipate risks, validate through IQ/OQ/PQ, and author clear work instructions. As production ramps to mid–high volume, you facilitate Kaizen events that trim tool changes and cut scrap. When a defect appears, you orchestrate a concise root-cause investigation, apply effective containment, and implement countermeasureswhile training operators and engineers to sustain the gains. All along, you uphold the TOMZ Quality Management System.
Your responsibilities
- Enable reliable production by minimizing equipment/tooling downtime and scrap.
- Run tool life studies and capability analyses to capture cost and throughput improvements.
- Lead production transfers and launches, building robust, scalable processes.
- Elevate manufacturing methods and controls to enhance quality and efficiency for both sustained and new products.
- Own ECO preparation and deployment; deliver operator and technician training.
- Create comprehensive process instructions; optimize layout, assembly methods, quality, safety, and product flow.
- Develop and qualify fixtures, tools, and equipment necessary for production.
- Analyze products and processes for cost, quality, and efficiency opportunities.
- Apply PFMEA and risk methodologies to identify and mitigate potential failures.
- Plan and support IQ, OQ, and PQ validations.
- Lead problem-solving: troubleshoot defects, find root causes, and implement durable countermeasures.
- Coach Engineering and Operations on process/equipment best practices.
- Disposition nonconforming product and define rework procedures.
- Facilitate Kaizen events; embed continuous improvement across the value stream.
- Adhere to the TOMZ Quality Management System and take on additional duties as assigned.
What you bring
- Meticulous attention to detail and quality.
- Ability to read drawings and specifications with GD&T.
- Proficiency with SolidWorks.
- Comfort with Microsoft Office and Adobe applications.
- Working knowledge of GMP and ISO 13485.
- Experience driving Lean initiatives and Kaizen workshops.
- Success in fast-paced medical device manufacturing environments.
Education & experience
- Bachelor’s degree in engineering or equivalent experience.
- Minimum 5 years’ experience in a regulated industry; medical device or aerospace contract manufacturing preferred.
Preferred skills
- Effective time management and prioritization.
- Self-directed contributor who thrives in teams.
- Strong written and verbal English communication.
Physical requirements
- Ability to bend, stoop, squat, kneel, and lift up to 20 pounds; team lift or mechanical assist required for items over 20 pounds.
- 20/20 vision (assisted or unassisted) to sort raw and nonconforming materials; good dexterity for small to medium products.
- Exposure to oil, grease, dust, metal particles, sparks, and sharp-edged materials; PPE or engineering controls may be required.
- Frequent keyboard input and computer operation.
