דרוש/ה מהנדס/ת NPI

Essential Job Duties and Responsibilities

• Experience in product transition from development to production- Must
• Work experience from Medical/Healthcare companies- Must
• Fluent business English: reading, writing and conversation – Must (job requires daily interactions in English).
• B.Sc. degree in mechanical engineering, Material engineering, Industrial Engineering, or another relevant degree.
• Experience in medical device Quality, Development, Manufacturing and/or Program or Project Management Leadership required.
• Ensures all work satisfies the requirements of the company’s Quality Manual.
• Lead efforts to analyse current project operations, make recommendations for improvement and coordinate the decision-making process.
• Maintain detailed documentation throughout all phases of transition to commercial manufacture, and transfer to ultimate manufacturer.
• Conducts risk analysis for products under development.
• Conduct feasibility studies of the design to determine ability to function as intended.
• Write and review customer proposals and/or scope changes.
• Organize interdepartmental activities ensuring completion of the project on schedule and within budget constraints in order to deliver the business solution to the customer
•  Manage resources of various departments to ensure that staff is appropriately loaded to meet program requirements.
• Provide Product Development design input to Product Development team.
• Provide Operations design input to Product Development team.
• Establish robust assembly processes for products developed by or transferred into Nordson Medical.
• Demonstrated ability to successfully bring products from design freeze to commercial manufacturing.
• Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
• Technical Knowledge in IT environment (ERP experience)- Advantage
• Familiarity with FDA QSR and ISO 13485 medical device regulations)- Advantage
• Knowledge of Six Sigma methodology- Advantage
• Knowledge in official investigation tools & methodology- Advantage
• Validation - Knowledge in validation methodology (IQ OQ PQ, TMV) - Advantage

• Location

• Katzrin, The Golan Heights