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Process Engineer
במקום העבודהמשרה מלאהIndustrial EngineeringMedical Devices
Join a medical device manufacturer’s Manufacturing Engineering team in Netanya. Lead engineering changes, qualify processes and suppliers, and provide hands-on support to production and final test lines.
תחומי אחריות
- Lead engineering changes from impact assessment through production implementation and formal closure.
- Plan and execute process verification, validation, and qualification activities, including IQ/OQ/PQ protocols and reports.
- Qualify new and replacement equipment and production lines at subcontractors in Israel and abroad.
- Support injection molding activities, including DFM reviews, mold qualification, and sample evaluation.
- Provide hands-on engineering support to production and final test lines.
- Define jigs, fixtures, and process parameters.
- Investigate nonconformances, perform root cause analysis, and drive corrective actions to closure.
- Develop, improve, and optimize manufacturing and assembly processes using production and yield data.
- Coordinate with Production, Quality, Regulatory, R&D, and Purchasing teams and manage internal and external stakeholders.
דרישות
- Bachelor’s degree in engineering; mechanical engineering is preferred.
- At least 3 years of experience in process engineering, manufacturing engineering, or a comparable production engineering role.
- Proven experience leading engineering or process changes from definition through implementation and closure.
- Experience with process verification, validation, or qualification.
- Experience working with external suppliers and subcontractors.
- Strong understanding of manufacturing and assembly processes, with hands-on production support experience.
- Practical experience using measurement equipment and analyzing data.
- Strong investigation, problem-solving, and root cause analysis skills.
- Fluent written and spoken English, including technical writing.
- Proficiency with Microsoft Office and Excel for data analysis.
יתרון
- Medical device manufacturing experience.
- Familiarity with FDA, ISO 13485, or other regulated manufacturing environments.
- Experience with IQ/OQ/PQ validation protocols and reports.
- Experience with injection molding, sheet metal, or machining.
- Experience qualifying overseas suppliers and subcontractors.
- SolidWorks/PDM experience and ability to read mechanical drawings.
- Experience with eQMS systems.
- Lean Manufacturing or continuous improvement experience.