BOM maintenance PLM:
High proficiency in drafting technical documents, Standard Operating Procedures (SOPs), and navigating Product Lifecycle Management (PLM) systems for bill of materials (BOM) management.
Multidisciplinary Troubleshooting:
Strong systems-level diagnostic skills to root-cause failures occurring at the intersection of mechanical, electrical, or firmware subsystems.
Validation Risk Management:
Practical proficiency in writing and executing validation protocols (IQ/OQ/PQ, TMV) and conducting risk analysis (pFMEA)
Requirements: Minimum of 2+ years of experience as a Manufacturing/Production Engineer within Medical Devices industry
Proven track record of executing Engineering Change Orders (ECOs) within a structured Quality Management system (QMS).
B.Sc. in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or Manufacturing Engineering from an accredited institution.
Fluent in English Hebrew
Advantage Experience:
Direct experience collaborating with external contract manufacturers (CMs) and suppliers on component and system level quality issues.
Familiarity with Arena and Priority systems
This position is open to all candidates.