Process Development Engineer II

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. 

Job Details/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 

Job Responsibilities (continued)

Working Conditions/Physical Requirements

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 maybe affected by your actions.
• Work co-operatively to highlight issues affecting Environmental Health and Safety

Knowledge, 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 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.

Qualifications/ Background Experiences

• 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.