Process Engineer

Eitan Medical is a fast-growing international medical device company that develops and manufactures innovative medical equipment. We are looking for a Process Engineer to join our Manufacturing Engineering team. Job Description: The Process Engineer will lead engineering changes and qualify manufacturing processes - on our production floor and at our subcontractors in Israel and abroad - while providing hands-on technical support to production. · Lead engineering changes (ECOs) end-to-end, from definition and impact assessment, through implementation on the production floor, to formal closure. · Plan and execute process verification and validation activities, including IQ/OQ/PQ protocols and reports. · Lead process qualification at subcontractors in Israel and abroad, including new and replaced equipment and production lines. · Support injection molding activities: DFM reviews with the molder, mold qualification and evaluation of samples. · Provide hands-on engineering support to production and final test lines, and define jigs, fixtures and process parameters. · Conduct technical investigations and root cause analysis as part of the NCMR process, and drive corrective actions to closure. · Develop, improve and optimize manufacturing and assembly processes, based on production and yield data. · Work closely with Production, Quality, Regulatory, R&D and Purchasing, and manage internal and external stakeholders. Direct Manager: Engineering Manager.

Requirements: Must Have: · B.Sc. in Engineering - mandatory; Mechanical Engineering - preferred. · 3-5 years of experience in Process Engineering, Manufacturing Engineering, or a similar production engineering role. · Proven experience leading engineering/process changes end-to-end, from definition through implementation and closure. · Experience with process verification, validation, or qualification activities. · Experience working with external suppliers and subcontractors. · Strong understanding of manufacturing and assembly processes, and proven hands-on experience supporting production. · Practical experience using measurement tools and equipment, and the ability to analyze data. · Strong problem-solving, investigation, and root cause analysis capabilities. · Fluent English - written and verbal, including technical writing Advantages: · Experience in the medical device industry. · Familiarity with FDA, ISO 13485, or other regulated manufacturing environments. · Experience with formal process validation protocols and reports (IQ/OQ/PQ). · Experience with manufacturing technologies such as injection molding, sheet metal & machining processes. · Experience working with, or qualifying processes at, overseas suppliers and subcontractors. · SolidWorks/PDM experience and the ability to read mechanical drawings. · Experience with eQMS systems. · Experience with Lean Manufacturing / Continuous Improvement methodologies. Computer Skills: · Proficiency in Microsoft Office applications, with a good level of Excel for data analysis. Personal Skills: · Strong technical and analytical capabilities. · Hands-on, practical, and solution-oriented approach. · Ability to lead cross-functional processes and drive stakeholders to deliver. · Excellent interpersonal and communication skills. · Self-motivated and independent. · Ability to manage multiple priorities and work effectively under pressure. · Team player with a proactive and continuous-improvement mindset.