Sr. Engineer Process Development

Terumo Aortic

Posted on: November 23, 2021

Closing: December 23, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

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.

Position Summary

Determine operations to produce products and develop processes to ensure quality, cost and efficiency requirements. Lead and manage key process items to bring new products through the design phase into efficient manufacturing operations.

Key Accountabilities:

    • Develop fixtures, gigs and gages
    • Document methods for manufacturing and inspection
    • Log evaluations into Engineering Notebooks
    • Design, evaluate, implement and monitor processes and operating systems for the manufacture aortic stent grafts
    • Develop and implement new Mfg. processes, execute process validations such as IQ, OQ, PQ protocols and reports
    • Lead the design transfer phase including product development, validation planning, design for manufacturability and assembly, Design of Experiments, process capability analysis, etc.
    • 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 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

      Internal Networking/Key relationships:

    • This position requires cooperating with different company departments, such as Quality, R&D, Regulatory, Operations, Sales, Marketing, Finance and the other team members of the department

      Minimum Skills and Capabilities:

    • Must work well under pressure
    • Knowledge of AutoCAD and SolidWorks
    • Knowledge of engineering statistics
    • Technical writing skills for manufacturing instructions, test methods, protocols, reports, etc. a must
    • 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

      Minimum Knowledge & Experience required for the position:

    • 4 - year engineering degree or equivalent experience
    • 8+ years of experience in a technical role in the medical device industry
    • 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

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.

Terumo Aortic

Posted on: November 23, 2021

Closing: December 23, 2021

Salary($): Undisclosed

Position Type: Full Time

Career Focus: Engineer

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