Sr. Engineer of Process Development

Headquartered in the U.S., our client is a division of a global company devoted to the research and development, manufacturing, and distribution of highly specialized products for Healthcare and Life Sciences worldwide.

This is a great step for someone who is looking to take a seat in a senior role and is looking to further progress down the line. If you are looking to take on a challenging role within a rapidly growing division that provides an A+ environment and excellent benefits, do not miss out on a potential opportunity to get your foot in the door.

• 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.
• 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.
• Other various responsibilities and projects, as necessary

• 4 - year engineering degree or equivalent experience
• 3+ 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. 21
  
  CFR
  820, ISO
  13485).
• 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
• Experience with polymers, medical grade metals and medical packaging

Please send suitable resumes in confidence to JPCuadra @

All your information will be kept confidential according to EEO guidelines.

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