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New Product Introduction Engineer
On-siteFull-timeIndustrial 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.
Responsibilities
- 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
Requirements
- 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
Nice to have
- Experience in medical devices
- Knowledge of CE and FDA regulations
- Experience with validation processes
- Experience with risk-based analysis and development processes