Process Development Engineer II

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 heartJob SummaryDetermine 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. Job Details/ResponsibilitiesDesign, 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 productsMonitor 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 necessaryLog evaluations into Engineering NotebooksDocument methods for manufacturing and inspectionCreate 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 Job Responsibilities (continued)Working Conditions/Physical RequirementsQUALITY REQUIREMENTS Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.EH&S REQUIREMENTSTake care of your own health and safety and that of others who maybe affected by your actions.Work co-operatively to highlight issues affecting Environmental Health and SafetyKnowledge, Skills and Abilities (KSA)Must work well under pressure.Knowledge of AutoCAD and SolidWorks or other CAD modelling software.Knowledge of engineering statistics and data analysisTechnical writing skills for manufacturing instructions, test methods, protocols, reports, etc., is requiredAble 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 liftingAbility to travel 10-15% of the time.Qualifications/ Background Experiences4 - year engineering degree or equivalent experience, Or a 2 - year technical degree or equivalent experience4+ years of experience in a technical role, preferably in the medical device industry or other regulated manufacturing industryWorking knowledge of equipment design, electro-mechanical, pneumatic components a plusWorking knowledge of Lean Manufacturing and Six Sigma a plusWorking knowledge of materials, injection moulding and procurementExperience and understanding of quality system regulations (e.g. 21CFR820, ISO13485).Project management experience in the medical device industryExperience with polymers, medical grade metals and medical packaging.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.