Sustaining Engineering Technician II

Terumo Aortic; Town of Florida (NY); On-site; USD 61,434,000 - 89,544,000; Full time

Benefits offered by this job

Annual bonus

Competitive hourly pay

Job summary

Terumo Aortic is seeking a manufacturing/quality engineer to provide technical support to improve the quality, efficiency, output and safety of aortic stent grafts and delivery systems. You will work with key suppliers to identify component improvements and support qualification, inspection methods, tooling, risk analysis and validation activities.

You will develop fixtures, jigs, tooling and equipment to support inspection and manufacturing, document methods, monitor process performance,

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 preferred.

Responsibilities

• Provide technical support to improve quality, efficiency, output and safety of devices.
• Support component qualification, inspection methods, tooling, risk analysis and validation activities.
• Collaborate with key suppliers to identify improvements meeting quality and cost requirements.
• Develop fixtures, jigs, gauges, prototypes, tooling and equipment.
• Document inspection and manufacturing methods and support validation activities.
• Perform DFMEA and PFMEA and monitor process performance with CAPAs and CQPs.

Skills

Statistical analysis

AutoCAD

SolidWorks

Technical writing

Experimentation

Prototype development

Process validation

Education

Technical degree or certificate

Tools

AutoCAD

SolidWorks

Job description

Provides technical support to improve the quality, efficiency, output, and safety of existing components and manufacturing processes. Supports critical component and supplier changes, component qualification, inspection methods, tooling, risk analysis, validation, and Quality System activities for aortic stent grafts and delivery systems.

Work with key suppliers to identify and develop component improvements that meet quality, cost, and business requirements and support critical component and supplier changes.

Support component qualification activities and improvements and help bring new or existing components through applicable 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.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Knowledge of engineering statistics and the ability to perform statistical analyses on data groups.
• Knowledge of AutoCAD and SolidWorks.
• Strong technical-writing skills for manufacturing instructions, test methods, protocols, reports, and related controlled documentation.
• Ability to organize and conduct experiments independently and analyze and solve technical problems.
• Hands-on ability to engineer and build prototypes, tooling, fixtures, processes, and equipment.
• Knowledge of component qualification, inspection methods, test-method validation, software validation, process validation, and risk-analysis methods, including DFMEA and PFMEA.
• Excellent written and verbal communication skills and the ability to work effectively under pressure.

Qualifications/ Background Experiences

• 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.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver’s seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. The hourly rate is $21.44 - $31.25/hour based on experience plus a 2% annual target bonus.

Join us and help shape wherever we go next!