Process Engineer

Description:

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.

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.