- Experience 0-5 Years
- Category Engineering
- Location West Chester, PA
DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a R&D Product Development Engineer, to be located in West Chester, PA.
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 R&D Product Development Engineer:
- Design and develop new implants and instrumentation and develop improvements and modifications to current products.
- Interact with surgeons, manufacturing, regulatory affairs, sales consultants, product managers, and other functional departments to define and develop product requirements and concepts.
- Work directly with surgeons for design concept development, prototype and cadaver evaluation, and clinical follow-up.
- Generate product models, concept layouts, and prints using a CAD software.
- Apply geometric dimensioning and tolerancing accordingly.
- Perform the required activities and generate the appropriate documents to ensure compliance with FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies.
- Develop mechanical test protocols according to ASTM standards and coordinates the activities required to fabricate test parts and complete mechanical testing.
- Work with manufacturing during the design stages to incorporate manufacturability into the product designs.
- Be responsible for all the designs from concept development through product launch.
- Be responsible for initial patent review of designs for freedom to operate.
- Perform other special projects and functions as assigned by the department manager.
- Assignment length for the Product Development Engineer is expected to last approximately 24 to 36 months.
- A minimum of a Bachelor’s degree in Engineering or related discipline is required; Mechanical or Bio Mechanical Engineering degree is preferred.
- A minimum of 2 years product development or design control experience in mechanical products is required.
- Experience working in medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements is preferred.
- Strong design quality experience with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses is preferred.
- Prior experience working with implantable medical devices is preferred.
- Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and an understanding of GD&T is required.
- Expertise in plastic injection molding product design and manufacturing preferred.
- Experience in value engineering and design-for-manufacturing is preferred.
- Knowledge of FDA 510(k) submissions process and regulation controls, and/or IDE clinical studies is preferred.
- Prior project management experience is also preferred.
- Demonstrated strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience.
- Strong problem solving, decision-making, and root cause analysis skills is required.
- The ability to effectively communicate concepts, ideas and knowledge is required.
- Proficiency utilizing the MS Office Suite (Word, Excel and PowerPoint) is required.
- Knowledge of CAD software (Pro Engineering, Pro-E, Solid Works or AutoCAD) is required.
- Willing to work with cadavers and within an Operating Room setting is required.