Industrialization & NPI Engineer — Lean Medical Device Operations

100Hires, Inc.; Berlin (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

TOMZ is seeking an Industrialization & NPI Engineer to drive lean medical device operations in Berlin, CT. You will transform designs into scalable manufacturing processes across machining, finishing, assembly, and anodize, while upholding the TOMZ Quality Management System.

You will lead cross-functional efforts to map product flow, run PFMEA, validate through IQ/OQ/PQ, and train teams to sustain improvements as production ramps to mid–high volume.

Qualifications

• Bachelor’s degree in engineering or equivalent experience.
• Minimum 5 years’ experience in a regulated industry; medical device or aerospace contract manufacturing preferred.
• Experience driving Lean initiatives and Kaizen workshops is highly valued.

Responsibilities

• Lead production transfers and launches, building robust, scalable processes.
• Apply PFMEA and risk methodologies; support IQ/OQ/PQ validations.
• Develop and qualify fixtures, tools and equipment for production.
• Create comprehensive process instructions and optimize production layout and flow.
• Coach Engineering and Operations on best practices and sustain gains.

Skills

GD&T reading

Lean manufacturing

Kaizen

English communication

Education

Bachelor’s degree in engineering

Tools

SolidWorks

Microsoft Office

Job description

Industrialization & NPI Engineer — Lean Medical Device OperationsWorksite: Berlin, CTMake an impactEvery 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 scenarioAn 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 responsibilitiesEnable 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 bringMeticulous 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 & experienceBachelor’s degree in engineering or equivalent experience.Minimum 5 years’ experience in a regulated industry; medical device or aerospace contract manufacturing preferred.Preferred skillsEffective time management and prioritization.Self-directed contributor who thrives in teams.Strong written and verbal English communication.Physical requirementsAbility 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.