Medical Device Process Innovation Engineer I

Terumo Aortic; Town of Florida (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

Terumo Aortic in the United States seeks a Manufacturing Engineer to design and optimize manufacturing processes for aortic stent graft production. You will lead process development, validation planning, and design transfer activities in a fast-paced environment.

The role requires strong CAD skills, statistical analysis, and quality-oriented mindset to deliver safe, compliant, and cost-efficient manufacturing operations.

Qualifications

• Bachelor’s degree in engineering or science required; Master’s preferred or equivalent experience in medical devices.
• 1 year of medical device industry experience or relevant advanced degree may substitute.
• Strong CAD modeling, statistical analysis, and technical writing skills are essential.

Responsibilities

• Design, evaluate, implement, and monitor manufacturing processes and systems for aortic stent grafts.
• Lead process validations (IQ/OQ/PQ) and design transfer activities.
• Perform risk analyses (DFMEA/PFMEA) and maintain required documentation.
• Support scale-up from small to large-scale manufacturing.
• Ensure quality systems compliance and audit readiness.

Skills

CAD modelling

Engineering statistics

Technical writing

Oral & written comms

Problem solving

Lean Six Sigma

Project management

Data analysis

Education

Bachelor’s degree in engineering/science

Master’s degree in engineering/science

Technical degree/certificate with equivalent experience

Tools

AutoCAD/SolidWorks

Prototyping tools

Job description

Terumo Aortic in the United States seeks a Manufacturing Engineer to design and optimize manufacturing processes for aortic stent graft production. You will lead process development, validation planning, and design transfer activities in a fast-paced environment.

The role requires strong CAD skills, statistical analysis, and quality-oriented mindset to deliver safe, compliant, and cost-efficient manufacturing operations.