NPI Engineer

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.• 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