At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** R&D Product Development **Job Sub** **Function:** Biomedical Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** West Chester, Pennsylvania, United States of America **Job Description:** **About MedTech** Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech **----------------** \#Li-Hybrid **----------------** An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. **----------------** We are searching for the best talent for **R&D Product Development Engineer** to be in **West Chester, PA** . This position is for the Surgeon Response Group (SRG), within the R&D organization. SRG’s mission is to support the hospitals and surgeons who use our products every single day. This position is focused on the development of new and customized medical devices based on a request from a surgeon. In this position, the candidate will engage with customers to design and develop new instrumentation for orthopedic procedures supporting the DePuy Synthes Trauma and CMF portfolios. The candidate will help lead the design and development of custom implants and instrumentation. This includes communicating with surgeons and sales consultants, understanding of clinical issues, defining the design parameters, and ensuring the correct product is provided to the customer. **Are you mechanically inclined?** This position allows you to own the project’s entire engineering development lifecycle, from conceptual designs, to crafting rapid prototypes, to releasing the finished good. Problem solving and a deep understanding of patient and surgeon needs is essential for this position. **Key Responsibilities** + Technically lead all aspects of the design process, including the identification of regulatory needs, developing design specifications, mitigating product risks, and building the engineering design history file. + Engage with surgeons and sales consultants to define user needs and design inputs. + Solve design problems utilizing CAD techniques, rapid and conventional prototyping and other available technologies. + Develop layouts and tolerance studies utilizing GD&T, and will participate in performing design evaluations (such as FEA, simulated use testing, dry labs and wet tissue labs etc.) + Work with manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes. + Perform complaint and field investigations supporting patient and customer safety + Perform quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects. **Qualifications** **Required:** + Bachelor’s Degree in Mechanical Engineering or Biomedical Engineering. + Two years of experience in designing and producing mechanical products or medical devices. + Experience with CAD software (Pro-E, Creo, Solidworks, etc.) is necessary. + Understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T are required. + Strong communication and interaction skills, with the ability to talk to surgeons, sales consultants, and marketing personnel. + Demonstrated creative design ability. + Proven success in bringing product from design through introduction on time. + “Hands-on” engineer. + Demonstrated ability to prioritize tasks and manage a varied workload. + Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.) is required **Preferred:** + Experience in medical device industry and knowledge of Regulatory Design Controls is desirable. _Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act._ _Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource._