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New Product Introduction Engineer
PresencialTiempo completoIndustrial EngineeringMedical Devices
Lead engineering activities that transfer new medical device products into commercial production, including process development, tooling, validation, documentation, supplier support, and manufacturing readiness.
Responsabilidades
- Manage new product introduction activities through commercialization
- Develop methods and processes, engineering drawings, tooling, production equipment, work instructions, bills of materials, and training materials
- Prepare process validation protocols and reports, design review packages, and technical justifications
- Support design transfer, manufacturing readiness, engineering changes, and nonconformity control
- Investigate failures, identify root causes, and implement corrective actions
- Create and maintain device master record documentation
- Redesign parts and assemblies for cost reduction
- Resolve technical product issues with suppliers
- Support maintenance of production-related equipment
- Collaborate with engineering, R&D, quality, suppliers, and manufacturing teams
Requisitos
- B.Sc. in Mechanical Engineering
- At least 3 years of experience as an NPI Engineer
- Proficiency in SolidWorks and PDM
- Experience with machining, sheet metal, and milling technologies
- Experience leading design-for-manufacturability, testability, and cost activities
- Experience leading process validation activities, including IQ, OQ, and PQ
- Familiarity with subcontractor and manufacturer collaboration
- Advanced knowledge of medical device quality systems and ISO 13485
- Fluent Hebrew and full professional proficiency in English
Se valora
- Experience in medical devices
- Knowledge of CE and FDA regulations
- Experience with validation processes
- Experience with risk-based analysis and development processes