NPI Engineer

Key Responsibilities:

• Lead product transfer from development to manufacturing
• Prepare and maintain technical documentation in compliance with ISO 13485 and FDA requirements.
• Initiate and manage ECOs and related documentation changes
• Write and execute validation protocols and participate in V&V activities
• Manage subcontractors and external vendors, including training and performance oversight
• Handle procurement activities, including issuing POs and supporting shipments
• Assemble and inspect prototypes; generate test and inspection reports
• Investigate customer complaints and perform root cause analysis

Requirements:

• B.Sc. in Mechanical Engineering or Practical Engineer (Mechanical)
• 1–3 years of experience in a similar operational/technical role
• Technical orientation and hands-on skills
• Strong organizational skills and attention to detail
• Ability to write clear and concise work instructions – in English
• Experience with Priority ERP – an advantage
• Experience with SolidWorks or similar CAD software – an advantage
• Previous work in production lines or medical device industry – an advantage
• Fluent in Hebrew and capable of reading/writing technical English
• Ability to work independently, methodically, and as part of a team
• Position requires travel (valid driver's license and personal vehicle required)

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