Senior Clinical Engineer

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: Santa Clara, California, United States of America Job Description: Johnson & Johnson MedTech is recruiting for a Senior Clinical Engineer for the OTTAVA Robotic Surgical System team. This position is located in Santa Clara, CA. 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 What We Do: The Ottava team envisions a future for robotic intervention that is targeted, minimally invasive, and personalized. Building upon a deep understanding of patient and physician needs, we are developing a platform for the next evolution of soft-tissue robotic care! Who We Are: We are a team of clinical, electrical, mechanical, mechatronics, robotic controls, and software engineers who are passionate about improving patient care. The team includes a wide range of experience levels from junior engineers to industry experts. We value autonomy and empower each other to take action while remaining a supportive and closely knit team. We take pride in our culture and are committed to building an environment that is inclusive and promotes diversity of thought through varied experiences and backgrounds. You: As a member of the Clinical Engineering team, you will join us on our journey to design and build a First-Of-Its-Kind Table-Integrated Robotic System. With a unique architecture, clinically differentiated instruments, and backed by an open digital ecosystem, we are looking for a high impact, user-centric clinical engineer to join our team to expand our procedure capability. You will have the opportunity to deeply immerse in the development of the clinical application with the Ottava system. You will develop understanding of the surgical practices in different specialities and translate that to user needs, establish clinical and engineering requirements and design inputs, consider clinical risks, solve technical problems in clinical settings and identify solutions to guide product development, and validation and regulatory strategy. This role offers high autonomy and growth opportunities within the team as we progress towards realizing our vision. If you enjoy being in the forefront of product development working alongside with clinicians and engineers, we love to hear from you. Performance Objectives and Responsibilities: Apply in-depth clinical, technical, and design control knowledge to collaborate with a cross-functional team to discover, define, develop, and validate a new product Partner with physicians and key clinical users to develop and characterize system performance, gather product feedback, and integrate their insights into product iterations Discover unmet clinical needs, establish customer requirements and provide clinical input to engineering design requirements Apply clinical knowledge and advanced data analysis technique to benchmark system performance against current practice in tissue models Develop bench models and metrics for evaluation to ensure clinical performance needs are met and maintained during development Develop new product clinical workflows, conduct clinical risk assessments, and propose effective mitigations for identified hazards Collaborate with pre-clinical and regulatory teams to support and advance pre-clinical studies Write plans, protocols, conduct formal testing, and report results of Design validation studies throughout the design process as required by FDA regulations Support developing customer training materials, user manuals, labeling, formative and summative assessments Support initial product launch and initial cases during customer site bring up Required Experience and Skills Hold a bachelor's degree in engineering (e.g. Biomedical, Mechanical) with a minimum of 5 years of related work experience in medical device industry (Master’s + 4 years of experience or PhD + 2 years of experience) Experience collaborating with physicians to gather clinical performance feedback and identify unmet needs Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams such as R&D, product management, human factors, professional education etc. Experience designing and conducting pre-clinical engineering studies to assess product performance and safety Proficient in identifying potential clinical risks and conducting thorough clinical harm analyses to enhance patient safety and product reliability Experience developing Design Validation strategy, protocol creation and testing Experience constructing customer and engineering design requirements Ability to draw conclusions and make recommendations based on technical and clinical inputs from multiple and varied sources Preferred Advanced degree (Masters, PhD, MD) Knowledge of endoscopic, laparoscopic procedures and operating room workflow Familiar with fundamental concepts in surgical robotics Strong knowledge of relevant regulations and standards for medical devices and robotic surgery platforms, including FDA regulations and guidance, and IEC and ISO standards. Demonstrated success in leading and delivering complex projects with an emphasis on usability from inception to completion. Have the ability to travel up to 15% of the time, internationally and domestic Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, rel