Manufacturing Engineer I: Process Improvement & DOE

Terumo Aortic; Florida; On-site; USD 90,000 - 130,000; Full time

Job summary

Terumo Aortic is seeking a Manufacturing/Process Engineer to support the manufacturing engineering team with SAP/HANA updates, process development, and cost-reduction initiatives. You will develop fixtures, jigs, tools, and gauges using AutoCAD or SolidWorks, while maintaining device history records and execution of validation protocols.

The role requires hands-on knowledge across electronics, plastics, metals and polymer packaging, plus experience in DOE, NCRs and CAPAs to drive continuous

Qualifications

• 3+ years of experience in a technical role in the medical device industry.
• Project management experience in the medical device industry.
• Hands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processes.
• Experience with polymers, medical grade metals and medical packaging.

Responsibilities

• Support the manufacturing engineering team with updating and implementing SAP/HANA.
• Develop and implement process layouts, tooling, gauges, and manufacturing instructions.
• Lead process improvements to increase productivity and reduce cost.
• Document and validate processes through IQ/OQ/PQ activities and CAPAs.
• Manage tools and equipment records and calibration.
• Assist in design transfer and development from R&D to manufacturing.

Skills

Technical leadership

Cross-functional collaboration

QMS & design control

Engineering problem solving

DOE (Design of Experiments)

Education

3+ years in medical device engineering

Tools

AutoCAD

SolidWorks

Job description

Terumo Aortic is seeking a Manufacturing/Process Engineer to support the manufacturing engineering team with SAP/HANA updates, process development, and cost-reduction initiatives. You will develop fixtures, jigs, tools, and gauges using AutoCAD or SolidWorks, while maintaining device history records and execution of validation protocols.

The role requires hands-on knowledge across electronics, plastics, metals and polymer packaging, plus experience in DOE, NCRs and CAPAs to drive continuous