Process Development Engineer II

Terumo Aortic; Town of Florida (NY); On-site; USD 85,000 - 120,000; Full time

Job summary

Terumo Aortic is seeking an experienced Manufacturing Process Engineer to design, evaluate, and optimize processes for the production of aortic stent grafts. You will lead design transfer, process validation, and scaling efforts, collaborating with R&D and Manufacturing teams to bring new components into production.

The role requires CAD proficiency (AutoCAD/SolidWorks), strong statistical and technical writing skills, and knowledge of Lean/Six Sigma.

Qualifications

• Bachelor’s degree in engineering or science; 3+ years in medical device industry.
• 10+ years in a technical role in the medical device industry.
• Experience with Lean Manufacturing and Six Sigma is a plus.
• Knowledge of quality system regulations (e.g. 21CFR820, ISO13485) is advantageous.

Responsibilities

• Design, evaluate, implement, and monitor processes and operating systems for the manufacture of aortic stent grafts.
• Develop and implement new manufacturing processes; execute IQ, OQ, PQ protocols and reports.
• Lead design transfer including product development, validation planning, DFM and design of experiments.
• Collaborate with R&D and Manufacturing Engineering to transfer component designs to production.
• Conduct risk analyses (DFMEA, PFMEA) and maintain related documentation.
• Support conversion of small-scale processes to large-scale operations.
• Perform statistical analyses and design tooling/fixtures for manufacturing and assembly.
• Monitor and improve process efficiency, output, and safety; collect and interpret data.

Skills

AutoCAD

SolidWorks

CAD modelling

Statistics

Technical writing

Communication

Problem solving

Tooling design

Education

Bachelor’s degree in engineering/science

3+ years in medical device industry

Tools

Lean Manufacturing

Six Sigma

Job description

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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.

POSITION IN ORGANISATION

Position in organization can be found on the Organizational Chart via the company intranet.

KEY DUTIES

• 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

DIMENSIONS & LIMITS OF AUTHORITY

COMPANY

REQUIREMENTS

• Must work within requirements of company handbook and policy statements.

Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system

QUALITY

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 REQUIREMENTS

• Take care of your own health and safety and that of others who may
• be affected by your actions.
• Work co-operatively to highlight issues affecting Environmental Health and Safety

QUALIFICATIONS & EXPERIENCE

Minimum requirements for the position:

• 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 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.
• 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.

Minimum Knowledge & Experience required for the position:

• Bachelor’s degree in engineering/science and a minimum of three years’ experience in the medical device industry or equivalent of
• 10+ years of experience in a technical role in the medical device 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 molding 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.