Sr. Engineer of Process Development

Open Scientific; Town of Florida (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

Open Scientific, located in the Town of Florida, is seeking a candidate for a senior technical role focused on producing aortic stent grafts. The position entails designing and implementing manufacturing processes while ensuring compliance with quality regulations.

The ideal candidate will possess a 4-year engineering degree, alongside extensive experience in the medical device sector and project management. Strong knowledge of manufacturing processes and quality systems is essential to excel in this role.

Qualifications

• 4-year engineering degree or equivalent experience.
• 3+ years in a technical role in the medical device industry.
• Experience with project management in medical device contexts.

Responsibilities

• Design and monitor processes for manufacturing aortic stent grafts.
• Lead design transfer and risk analysis for medical products.
• Support conversion of small-scale to large-scale manufacturing operations.

Skills

Technical project management

Experience with medical device regulations

Process validation

Knowledge of polymers and medical packaging

Education

4-year engineering degree

Tools

Manufacturing processes

Data analysis tools

Job description

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.

Job Description

• 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

Qualifications

• 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. 21CFR820, ISO13485).
  
• 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 @ openscientific.com

Additional Information

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

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