Sustaining Engineer II

Terumo Cardiovascular Group; Town of Florida (NY); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

Health, dental and vision benefits

401(k) with matching

Job summary

Terumo Aortic, a part of Terumo Cardiovascular Group, is seeking an experienced engineer to provide manufacturing support for aortic stent-graft production. The role involves tool development, process validation, supplier collaboration, and quality system adherence to drive efficient manufacturing operations.

Ideal candidates have 5+ years in medical devices, strong CAD skills (AutoCAD/SolidWorks), and a track record in DFMEA/PFMEA, GMP/ISO13485 environments, and cross-functional teamwork.

Qualifications

• 4-year engineering degree or equivalent experience.
• 5+ years of experience in a technical role in the medical device industry.
• Technical writing skills for manufacturing instructions, test methods, protocols, reports.

Responsibilities

• Provide Engineering support to improve quality and efficiency for existing components.
• Determine critical components and supplier changes to support business needs.
• Support key process items to bring new components through the design phase into efficient manufacturing operations.
• Work with key suppliers to identify and develop improvements to ensure quality and cost requirements.
• Responsible for component qualification activities and improvements.
• Develop fixtures, jigs, and gages to assist with component inspection processes.
• Document methods for inspection processes.
• Log evaluations into Engineering Notebooks.
• Design, evaluate, implement, and monitor processes and operating systems for the manufacture of aortic stent-grafts.
• Develop and implement new Mfg. processes, execute process validations such as IQ, OQ, PQ protocols, and reports.
• Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation.
• Support the conversion of small-scale processes into commercially viable large-scale operations.
• Work with Research and Development to develop and transfer new component designs to manufacturing.
• Perform statistical analyses on data groups.
• Present data and projects to upper management when required.
• Lead TMVs and software validation as necessary
• Monitor and improve the efficiency, output, and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.
• Support Quality system items such as CAPAs, NCRs, CQPs, TMVs, etc.
• Other various responsibilities and projects, as necessary

Skills

AutoCAD

SolidWorks

Engineering statistics

Cross-functional teamwork

Experimentation

Problem solving

Prototyping

Communication skills

Software proficiency

Project management

Quality system knowledge

Polymers and metals in medical devices

Electronics and motion control

Education

Bachelors in Engineering

Tools

AutoCAD

SolidWorks

Job description

Select how often (in days) to receive an alert:

At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.

The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.

Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.

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.

Join us and help shape wherever we go next!

• Provide Engineering support to improve quality and efficiency for existing components.
• Determine critical components and supplier changes to support business needs.
• Support key process items to bring new components through the design phase into efficient manufacturing operations.
• Work with key suppliers to identify and develop improvements to ensure quality and cost requirements.
• Responsible for component qualification activities and improvements
• Develop fixtures, jigs, and gages to assist with component inspection processes.
• Document methods for inspection processes
• Log evaluations into Engineering Notebooks
• Design, evaluate, implement, and monitor processes and operating systems for the manufacture of aortic stent-grafts.
• Develop and implement new Mfg. processes, execute process validations such as IQ, OQ, PQ protocols, and reports.
• Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation.
• Support the conversion of small-scale processes into commercially viable large-scale operations.
• Work with Research and Development to develop and transfer new component designs to manufacturing.
• Perform statistical analyses on data groups.
• Present data and projects to upper management when required.
• Lead TMVs and software validation as necessary
• Monitor and improve the efficiency, output, and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.
• Support Quality system items such as CAPAs, NCRs, CQPs, TMVs, etc.
• Other various responsibilities and projects, as necessary

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Must work well under pressure.
• Knowledge of AutoCAD and SolidWorks
• Knowledge of engineering statistics
• Able to work closely with a variety of people and teams within the company.
• Ability to organize and conduct experiments independently.
• Ability to analyze and solve technical problems.
• Hands-on abilities to engineer tooling, processes, and equipment.
• Hands-on experience building prototypes, tooling, and fixtures.
• Excellent written and verbal communication skills
• Proficient in software applications
• Project management experience in the medical device industry
• Experience and understanding of quality system regulations (e.g. 21CFR820, ISO13485).
• Project management experience in the medical device industry
• Experience with polymers, medical-grade metals, and medical packaging
• Hands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processes

Qualifications/ Background Experiences

• 4 - year engineering degree or equivalent experience
• 5+ years of experience in a technical role in the medical device industry
• Technical writing skills for manufacturing instructions, test methods, protocols, reports, etc. a must

It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.

Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami