Process Development Engineer II

Terumo•Davie, FL

4d•Onsite

About The Position

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! Advancing healthcare with heart www.terumoaortic.com Job 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.

Requirements

Must work well under pressure.
Knowledge of AutoCAD and SolidWorks or other CAD modelling software.
Knowledge of engineering statistics and data analysis
Technical writing skills for manufacturing instructions, test methods, protocols, reports, etc., is required
Able to work closely with a variety of people and teams within the company.
Ability to organize and conduct experiments independently.
Ability to analyse and solve technical problems.
Hands on abilities to engineer tooling, processes, and equipment.
Good oral and written communication skills (English)
Hands on experience building prototypes, tooling, and fixtures.
Sit/Stand/Walk 8 hours per day.
Light lifting
Ability to travel 10-15% of the time.
4 - year engineering degree or equivalent experience, Or a 2 - year technical degree or equivalent experience
4+ years of experience in a technical role, preferably in the medical device industry or other regulated manufacturing industry
Working knowledge of equipment design, electro-mechanical, pneumatic components a plus
Working knowledge of Lean Manufacturing and Six Sigma a plus
Working knowledge of materials, injection moulding and procurement
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.

Nice To Haves

Working knowledge of equipment design, electro-mechanical, pneumatic components a plus
Working knowledge of Lean Manufacturing and Six Sigma a plus
Working knowledge of materials, injection moulding and procurement
Project management experience in the medical device industry
Experience with polymers, medical grade metals and medical packaging.

Responsibilities

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.
Work with Research & Development and Manufacturing Engineering to develop and transfer new component designs to manufacturing.
Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation.
Support the conversion of small-scale processes into commercially viable large-scale operations.
Perform statistical analyses on data groups.
Design advanced tooling and fixtures that will be used for the manufacturing and assembly of products
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.
Lead TMVs and software validation as necessary
Log evaluations into Engineering Notebooks
Document methods for manufacturing and inspection
Create change requests within the company’s change management system.
Present data and projects to upper management when required.
Other various responsibilities and projects, as necessary