Manufacturing Process Engineer - Medical Devices

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

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