Senior Research & Development Engineer

Job description

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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: We are searching for the best talent for a Senior Research and Development Engineer, to join our Orthopaedics team. This is a hybrid role located in West Chester, PA. Purpose: The Senior R&D Engineer will be responsible for the design and development aspects of complex systems and projects, technically leading cross-functional project teams through all phases of the product life-cycle, and will often organize, plan, execute and oversee projects through product launch, commercialization, and post market surveillance. In this role, you will design and develop new implants and instrumentation and/or support in-market products through their product life-cycle within multiple cross-functional project teams. This includes communication with customers, e.g., Health Care Professionals, marketing and sales consultants, understanding of clinical issues, defining the design parameters, and ensuring the product which is provided to the customer meets the functional requirements.  Furthermore, the Senior R&D Engineer will be an integral resource to the R&D team, as a leader and mentor for associate R&D engineers and R&D engineers. Key Responsibilities: 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, regulatory, etc.). Coordinates with design engineers, marketing, quality, supply chain, manufacturing, regulatory affairs. Health Care Professionals, and other functional departments to define and develop product requirements and concepts on new or existing products. Solve complex design problems utilizing CAD techniques, rapid and conventional prototyping, and other available technologies. Generate design concepts and prototypes independently. Perform design evaluations (such as tolerance analysis, GD&T, FEA, simulated use testing, dry labs and wet tissue/cadaver labs etc.)  Document clinical and surgical technique observations to create meaningful design solutions. Development and execution of design verification and validation plans and activities, and test plan formation and execution to support global regulatory strategy. Performs the required activities and generate the appropriate documents to ensure compliance with MDR; FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies. Drive initial patent review and freedom to operate activities from concept to launch. Collaborate with supply chain, manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and support production documentation. Designs and executes or coordinates mechanical tests and scientific experiments, present data and conclusions with appropriate analysis and write technical reports. Independently determines and develops approaches to solutions with technical guidance on the most unusual or complex problems by using six sigma methodologies. Demonstrate proficiency in the application of design controls and development processes and support the project leader with aspects of the project management functions including scope definition, and contingency planning. Act as a subject matter expert on existing product lines and detailed knowledge of applicable anatomic pathologies as well as treatment options. Works directly with Health Care Professionals, and other functional departments to define and develop product requirements and design concepts/prototypes on new/or existing as well as wet tissue/cadaver evaluation, and clinical follow-up. Understands and follows the New Product Development process accurately and maintains high quality design validation and verifications. Recognized as a leader on projects and assignments. Act as a mentor for interns / Co-Op's. May be responsible for operating within a budget and provide input on budget allocation and prioritization. Carries out smaller projects of limited complexity and scope under general supervision. Perform complaint investigations and field investigation activities in support of patient/customer safety. Perform quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects. Support Operations projects associated with Cost Improvement Projects and Production Transfers. Performs other special projects and functions as assigned. 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. Responsible for communicating business related issues or opportunities to next management level. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Required Qualifications: BS in Mechanical Engineering, Biomedical Engineering, or equivalent. Minimum of six years of experience in the design and development of medical devices, mechanical products, or biomechanical systems, including multi-component systems. Strong experience with CAD software (Pro-E, Creo, Solidworks, etc.) Experience in identifying user needs (VOC), medical device design principles, material selection, ability to verify and validate design concepts, and understanding design failure modes. Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T. Strong communication and interaction skills, with the ability to interface with Health Care Professionals and sales/marketing personnel. Possess strong organizational skills to support all aspects of the project management functions including scope definition, budgeting, and contingency planning. Excellent 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 required. 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. Demonstrated success in bringing products from design through introduction on time. Demonstrated creative design ability. Ability to work with wet tissues/cadaver and within an Operating Room setting. Must have the ability to effectively communicate concepts, ideas and knowledge to other individuals, Health Care Professionals, customers and/ or teams, and work effectively as a technical l