Johnson & Johnson Careers
Product Development Engineer
Requisition ID: 6343180709
DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for Product Development Engineer in the Trauma R&D department located in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offers 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. Our focus is on activating insights to develop innovative, comprehensive solutions, to advance patient care.
Design and develop new implants and instrumentation. This includes communication with surgeons and sales consultants, understanding the clinical issues, defining the design parameters to support AO philosophies, and ensuring the correct product is provided to the customer.
- Designs and develops new implants and instrumentation and develops improvements and modifications to current products.
- Interacts with surgeons, manufacturing, regulatory affairs, sales consultants, product managers, and other functional departments to define and develop product requirements and concepts.
- Works directly with surgeons for design concept development, prototype and cadaver evaluation, and clinical follow-up.
- Generates product models, concept layouts, and prints using a CAD software. Apply geometric dimensioning and tolerancing accordingly.
- Performs the required activities and generates the appropriate documents to ensure compliance with FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies.
- Develops mechanical test protocols according to ASTM standards and coordinates the activities required to fabricate test parts and complete mechanical testing.
- Works with manufacturing during the design stages to incorporate manufacturability into the product designs.
- Responsible for all the designs from concept development through product launch.
- Responsible for initial patent review of designs for freedom to operate.
- 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.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Performs other special projects and functions as assigned by the department manager.
- 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 a plus.
- A minimum of two years of experience in the design and development of mechanical products, or biomechanical systems, including multi-component systems, in a highly regulated industry is required.
- Working knowledge of CAD software (Pro-E, Medusa, AutoCad, Ideas, etc.) is required.
- Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T are highly preferred.
- Prior project management experience preferred.
- Experience in medical device industry and knowledge of Regulatory Design Controls 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 preferred.
- Strong communication and interaction skills, with the ability to interface with surgeons and sales/marketing personnel is required.
- Demonstrated success in bringing product from design through introduction on time is preferred.
- This position will be based in West Chester, PA and may require up to 20% travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Pennsylvania-West Chester
Synthes USA Products, LLC (6317)
R&D Engineering (R&D)