Sustaining Eng Tech II – Medical Devices

Terumo Cardiovascular Group

Town of Florida (NY)

On-site

USD 61,478,000 - 89,544,000

Full time

14 days+

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Benefits offered by this job

Annual bonus

Paid vacation

Health benefits

401(k) with match

Life insurance

Disability insurance

Tuition reimbursement

Travel assistance

Job summary

Terumo Aortic in Sunrise, Florida is seeking a qualified engineer to provide technical support, improve manufacturing processes, and validate components for aortic stent grafts and delivery systems. You will work on component qualification, tooling development, and process validation with a focus on quality and reliability.

The role requires experience in engineering and manufacturing environments, familiarity with DFMEA/PFMEA, and skills in AutoCAD and SolidWorks.

Qualifications

Technical degree or certificate, or equivalent education and experience.
Experience in a technical, engineering, manufacturing, component, tooling, inspection, or validation environment.
Medical-device industry experience is preferred.

Responsibilities

Provide technical support to improve the quality, efficiency, output, and safety of existing components and manufacturing processes.
Support component qualification activities and improvements and help bring new or existing components through design and qualification phases.
Develop fixtures, jigs, gages, prototypes, tooling, and equipment that support component inspection, manufacturing, testing, and process improvement activities.
Document inspection and manufacturing methods and support test-method validation, software validation, and other required validation activities.
Support the design, evaluation, implementation, monitoring, and operation of systems and processes used to manufacture aortic stent grafts and delivery systems.
Help develop and implement manufacturing processes and execute process-validation activities, including IQ, OQ, and PQ protocols and reports.
Conduct risk and statistical analyses, including DFMEA and PFMEA, maintain required documentation, monitor process performance through observations and data, and support CAPAs, NCRs, CQPs, TMVs, and other Quality System activities.