DePuy Synthes Inc, part
of the Global Orthopeadics Group within Johnson & Johnson Medical Devices
is recruiting for a New Product
Development Engineer - Trauma R&D, DePuy Synthes to be located in West
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.
Senior R&D Product Development Engineer, Trauma will design and develop new
implants and instrumentation. He/she will develop improvements and
modifications to current products. This individual will interact with surgeons,
manufacturing, regulatory affairs, sales consultants, product managers, and
other functional departments to define and develop product requirements and
- The R&D Product Development Engineer, Trauma will design and develop new implants and instrumentation and develop improvements and modifications to current products.
- He/ she will interact with surgeons, manufacturing, regulatory affairs, sales consultants, product managers, and other functional departments to define and develop product requirements and concepts.
- This individual will work directly with surgeons for design concept development, prototype and cadaver evaluation, and clinical follow-up.
- The R&D Product Development Engineer, Trauma will generate product models, concept layouts, and prints using a CAD software.
- He/she will apply geometric dimensioning and tolerancing accordingly.
- This individual will 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.
- The R&D Product Development Engineer, Trauma will develop mechanical test protocols according to ASTM standards and coordinates the activities required to fabricate test parts and complete mechanical testing.
- He/she will work with manufacturing during the design stages to incorporate manufacturability into the product designs.
- This individual will be responsible for all the designs from concept development through product launch.
- The R&D Product Development Engineer, Trauma will be responsible for initial patent review of designs for freedom to operate.
- He/she will know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- This individual will diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. He/she will perform other special projects and functions as assigned by the department manager.
- A minimum of a Bachelor’s degree in Engineering or related discipline is required; Mechanical Engineering degree is preferred.
- A minimum of 2 years product development or design control experience in mechanical products is required.
- Regulated industry experience is required; medical device experience 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 in addition to interpersonal skills that foster conflict resolution as it relates to technical situations is all required.
- The ability to effectively communicate concepts, ideas and knowledge to upper management, other individuals, customers and/ or teams across the organization 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.
- This position is located in West Chester, PA and may require up to 10% travel including international.
United States-Pennsylvania-West ChesterOrganization
Synthes USA Products, LLC (6317)Job Function
R&D Engineering (R&D)