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.
This position is open to all candidates.