Details: Rapidly expanding medical device business unit of a Fortune 200 company seeks an NPI Engineering Manager to join its growing team. This is a high profile division and a real focal point of the company. This is a home grown technology that was pulled out of another internal business unit and made into a separate BU to provide the focus and investment for growth. This is a high growth dynamic business for the company. There are large capital investments being made involving a number of new equipment purchases to support new revenue opportunities. Initially, this engineering manager will oversee 6 engineers (NPI, Sustaining, and Process) but the group will double in size over the next 6 months with you being the key person hiring these individuals. Overall, this site is expected to grow 5 fold over the next couple of years and as we recruit on this role, we are also seeking someone that can be promoted to a plant manager level within 2-3 years. That said, this is a high visibilty role with very good growth potential. The company as a whole is a very metric driven operation that really recognizes solid performance. We are looking for a highly motivated individual that has a demonstrated track record of taking on more and more challenge. Ideal candidates will have proven leadership background leading NPI/Transfer projects within a medical device and/or industry where process validation is critical.Essential Functions: Plans and directs outsourced, project-specific Engineering resources and blends/aligns their activities with those internal resources of Supply Chain, Operations, Sales/Customer Service, Marketing and Quality. Participates in the formulation of new product Performance Requirements and the translation into Design Specifications and product concepts Interfaces with customers, Sales and Marketing on technical matters relating to new products Develops new product prototypes to validate product designs as meeting Performance Requirements, quality and cost goals Interprets drawings, schematics and technical specifications Ensures designs can be easily manufactured, serviceable, modular and sustainable Responsible for all stages of manufacturing development of new products: initial quotes, tool vendor selection, tool design, build, approval and validation of production process. Knowledgeable of modern design validation tools/techniques and methodologies, such as FEA, Kinematics, DFMA and DFSS Oversees the creation and control of layouts, product drawings, specifications and Bills of Material, according to company requirements Responsible for new product development project execution according to agreed cost, quality, product performance and timetable requirements; prepares periodic status reports for Leadership Leads technical discussions to resolve issues Develops detailed project schedules and budgets Leads negotiation responsibilities for contract design work. Understands the business case and has an appreciation of financial/analytical issues and profit and loss implications. Researches available technologies with the objective of improving product quality, reducing cost or increasing employee safety; develops sensible plans to evaluate, implement and then to audit the efficacy of completed technology improvement projects. Keeps abreast of industry standards and regulatory requirements through competitive analysis, trade publications, and participation in outside organizations. Determines the required design parameters for testing of products and the preparation of test packages. Understands all applicable testing requirements. Drives the review/approval of new design concepts and insures new products are designed and tested to meet applicable functional and regulatory requirements. Maintains a working knowledge of all specifications and procedures required for the in-house and field-testing of Company products. Orchestrates methods and procedures for product testing with internal and external resources.
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