Industrialization & NPI Engineer -- Lean Medical Device Operations

Job Description

Job Description

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 anodize—driving 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 countermeasures—while 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.