Process Engineer
Stratasys
- קרית גת
- משרה קבועה
- משרה מלאה
- Monitor, interact, report, and support all engineering activities for resin production in multidisciplinary products according to FDA/MDR standards regulations.
- Define resin production bottling and packaging process, continuous improvements, and maintenance.
- Performed validation process- IQ, OQ, and PQ (cleaning, methods, process, equipment, and software)
- Implement new products and escort newly developed products to the production floor.
- Analyze, investigate, and implement corrective and preventive actions for quality issues and customer complaints.
- Lead 2nd source & cost-saving activities from engineering aspects.
- Manage sub-contractors for assembly lines and mechanical/software manufacturing.
- Coordinate and participate with local CPE and NPI teams on design for production activities.
- Control products' ECO processes and implementation
- Responsible for editing Production files, Production documentation, BOMs, jigs, and tools design
- BSc degree in Chemistry/Material Engineering - mandatory.
- Minimum 3 years of proven experience in a medical manufacturing/production environment
- Minimum 3 years of proven experience in cleaning, methods, process, equipment, and software validation. - Mandatory
- Experience with validation process- IQ, OQ, and PQ (cleaning, methods, process, equipment, and software) - Mandatory
- Strong written and verbal English language communication skills.
- Ability to present technical information and effectively communicate across all levels of the organization.
- Experience in manufacturing technology activities - new line establishment, milling/grinding process, automation lines HMI, etc. - an advantage.
- Experience with leading production line processes and problem-solving
- Familiar with control software, ERP, and Agile systems-- an advantage.
- Good communication skills. Team player and able to build and maintain relationships with both internal and external departments.
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