Medical Device NPI & Industrialization Engineer

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

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.