Process Engineer

Eitan Medical; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

Eitan Medical is seeking a Process Engineer to join our Manufacturing Engineering team in the United States. The role involves leading engineering changes on the production floor and at subcontractors, and providing hands-on technical support to production.

The engineer will verify and validate processes, qualify subcontractors, support injection molding activities, and drive corrective actions through NCMR analyses, collaborating with cross-functional teams including Quality, Regulatory, R&D

Qualifications

• B.Sc. in Engineering is mandatory.
• Mechanical Engineering is preferred.
• 3-5 years in Process or Manufacturing Engineering roles.
• Experience leading end-to-end process changes from definition to closure.
• Experience with process verification/validation or qualification activities.
• Experience with external suppliers/subcontractors.
• Fluent English, written and verbal, including technical writing.

Responsibilities

• Lead engineering changes (ECOs) end-to-end from definition to closure.
• Plan and execute IQ/OQ/PQ protocols and reports.
• Lead process qualification at subcontractors in Israel and abroad.
• Support injection molding: DFM reviews, mold qualification, samples evaluation.
• Provide hands-on engineering support to production and final test lines; define jigs and fixtures.
• Conduct root-cause analysis as part of NCMR; drive corrective actions to closure.
• Develop, improve and optimize manufacturing and assembly processes using production data.
• Collaborate with Production, Quality, Regulatory, R&D and Purchasing; manage internal/external stakeholders.

Skills

Process engineering

Manufacturing engineering

Data analysis

Problem solving

Cross-functional

Education

B.Sc. in Engineering

Mechanical Engineering

Tools

SolidWorks

PDM

eQMS

Excel

Job description

Job 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.

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.