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Senior Product Development Engineer III, Spine
Requisition ID: 0321180122
DePuy Synthes Spine, Inc a member of Johnson & Johnson's Family of Companies is recruiting for a Senior Product Development Engineer III, Spine to be located in Raynham, MA.
DePuy Synthes is a Johnson & Johnson company that is one of the leaders in the medical device industry. Our implants and instruments are used by orthopaedic surgeons to treat patients with conditions resulting from traumatic injuries, degenerative diseases, deformities, and sports related injuries. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Senior Product Development Engineer III will be responsible for:
- Design and develop new implants, instrumentation and procedural solutions pertaining to spine surgery.
- This includes communication with surgeons and sales consultants, understanding of clinical issues, defining the design parameters, and ensuring the correct product is provided to the customer.
- The design and development aspects of complex systems and projects, technically leading cross-functional project teams through all phases of the product development process, and will often organize, plan, execute and oversee projects through product launch, commercialization, and post market surveillance.
- The candidate will act as a technical team leader and in some cases project leader as a member of a cross-functional project core team (marketing, manufacturing, quality, testing, supply chain etc.).
- The candidate will be responsible to work with surgeons, marketing and sales to define and refine design inputs, generate design concepts and prototypes independently, perform meaningful and timely design evaluations (such as tolerance analysis, FEA, simulated use testing, dry labs and wet tissue labs etc.), and oversee generation of documentation of clinical and surgical technique observations to create meaningful design solutions.
- The candidate will be responsible for initial patent review and freedom to operate activities from concept to launch.
- The candidate will also be responsible for development and execution of design verification and validation plans and activities, and test plan formation and execution to support global regulatory strategy.
- The Senior Product Development Engineer III can mentor entry level engineers and will oversee manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation.
- The candidate must demonstrate strong proficiency in the application of design controls and development processes, and will be responsible for all of the designs from concept development through product launch.
- This individual should possess strong organizational skills to support all aspects of the project management functions including scope definition, budgeting, and contingency planning.
- The candidate must have a demonstrated ability to prioritize tasks and manage a varied workload, exhibit strong written and verbal communication skills, and interface effectively with peers, cross functional project teams, management, sales and surgeons.
- The individual will also be expected to have an expert knowledge of our product lines and detailed knowledge of various spinal pathologies, and will be an active participant in sales training and in providing ongoing product support to the field.
- A minimum of a Bachelor’s degree in Mechanical Engineering or Biomedical Engineering with mechanics or electrical focus is required.
- A Master’s Degree is desired.
- A minimum of 4 years of professional experience (not including co-op, internship, and research) new product development experience or equivalent is required. Experience with medical devices (Spine or Orthopedic) is highly preferred.
- Experience in identifying user needs (VOC), design principles, material selection, ability to verify and validate design concepts, and understand design failure modes is required.
- Strong track record utilizing computer aided design (CAD) to develop a product is a must. Experience with Unigraphics NX or ProE/Creo would be preferred.
- Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T are required.
- Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc) is required.
- Experience with FDA Medical Device guidelines is preferred.
- The candidate must have a demonstrated background in developing creative solutions to solve design problems.
- Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience.
- A successful track record of leading and influencing others without authority, participating on cross-functional teams and solid negotiating skills to bring products from concept to launch is required.
- The ability to look beyond conventional solutions and familiarity with technologies extending beyond traditional spine therapies and products is desired.
- Experience with developing and launching sterile products is preferred.
- Interaction with industrial designers previously is desired.
- Must have the ability to effectively communicate concepts, ideas and knowledge to other individuals, surgeons, customers and/ or teams, and work effectively as a technical leader and sometimes as a project leader.
- The ability to review and critically assess patents and other forms of intellectual property is preferred.
- This position is based in Raynham, MA and may require up to 20% domestic and international travel.
DePuySynthes Products Inc (6149)
R&D Engineering (R&D)