DePuy Synthes is recruiting for a Senior Engineer, Product Management/ New Product Introductions (NPI) for Trauma, Extremities, CMF (craniomaxillofacial) and Animal Health to be located in West Chester, PA.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.\
You will be a core member of the DePuy Synthes Supply Chain Product Management (SCPM) group. You will use engineering knowledge of Product Management operations to function as an integral member of an NPI team developing, designing, validating & starting up world-class Product Management & assembly operations that ensure product quality, cost & performance objectives while concurrently providing design, quality, marketing & financial inputs.
The successful candidate will work within a cross-functional project team through all phases of the product development process, planning and executing projects through the product launch. He/she will work closely with members of the project core team (R&D, Quality Engineering, Marketing, Finance, Sourcing, Plan, External Manufacturers etc.,) to define user needs, generate design concepts and prototypes, perform design evaluations (such as tolerance analysis, FEA, DOE's, simulated use testing, etc.), and support development of product and process validation plans and testing. You will have the opportunity to be involved in test method development and evaluation of the proposed design.
The Senior Product Management Engineer will be part of a multi-functional team and suppliers to optimize designs for manufacturability and produce prototypes. You should demonstrate an understanding in the application of design controls and development processes. You should have the ability to prioritize tasks and handle a varied workload, exhibit strong written and verbal communication skills and interface effectively with others in the project team.
You will also be expected to develop a deep knowledge of our product lines and detailed knowledge of various TECA (Trauma, Extremities, CMF, and Animal Health) products.
- Collaborating with R&D, Quality engineers and External Manufacturers in developing new product designs within a cross-functional team environment; specifically, to develop innovative Product Management solutions for soft tissue and shoulder reconstruction implantable devices.
- Establishing the relationship between product design features and the selected methods required to manufacture the product.
- Providing detailed assessments and critical Design for Product Management review of engineering designs/drawings of components and assemblies. He/she will participate in design reviews to assess the design intent, manufacturability, proper dimensioning and tolerancing of components and assemblies to allow product to transition into the Product Management environment.
- Managing prototypes used in new product development, including selecting the most appropriate prototype methods and executing prototype development to support new product design trials.
- Completing financial estimates of components and assembly Cost of Goods Sold.
- Providing analysis and recommendations for feature and cost tradeoffs, during the design phase of new products. Developing comprehensive, cost effective Product Management strategies, including supplier selection, to drive product team decisions on sourcing to achieve cost and time targets.
- Providing technical support to external manufacturers in process development, characterization, validation and stabilization.
- Supporting ERP and Quality System assessments and deliverables (Functional Impact Assessments, Routers, Drawing Reviews, Product Quality Plan, process related NPI Non-conformances)
- Bachelor's degree in an engineering discipline.
- Minimum 6 years of engineering experience with a BS, or 4 years with MS in engineering.
- Minimum 3 years experience in a Supply Chain environment (i.e. for process development, cycle time, yield and cost improvements).
- Experience working in highly regulated industry is required with medical device experience preferred.
- Demonstrated ability to manage design and Product Management-related activities within the requirements of 13485 Design Control requirements.
- Strong technical communication and negotiation skills and demonstrated ability to work independently with external suppliers.
- Knowledge in the application of Design for Product Management (DFM), including industry best practices and experience in applying DFM to new product designs.
- Experience in Product Management Cost analysis.
- Experience with regulations and standards (IEC 60601 and IEC 60825).
- Technical expertise around a multitude of enabling surgical technologies (e.g. Electronics, Computer Sciences, Software Development, Navigation, Data analytics, Sensors, Optics, Acoustics, Energy, etc.).
- Experience working with an integrated cross-functional new product development team.
- A broad knowledge of medical device Supply Chain processes and applications (broad understanding of available Supply Chain technologies, assembly and inspection techniques and automation is preferred).
- Proficient knowledge of Process Excellence / Six Sigma statistical analysis techniques and its application in Product Management/ NPI processes.
United States-Pennsylvania-West Chester-
Medical Device Business Services, Inc (6029)