Senior Clinical Engineer - Monarch Urology

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

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Robotics and Digital Solutions, part of Johnson & Johnson MedTech family of companies, is recruiting for a Senior Clinical Engineer for the Monarch Urology team. This position is located in Santa Clara, CA.

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/.

At Johnson & Johnson MedTech, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Santa Clara), Cincinnati, and Seattle. You’ll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals’ skills and improves patient outcomes.

The Monarch 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!

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.

As a member of the Monarch Urology team you will join us on our journey to design and build one of the world's most advanced medical robotic platforms. You will have the opportunity to define user needs, establish clinical and engineering requirements, consider clinical risks, and identify solutions to guide product development. This role offers high autonomy and growth opportunities within the team as we progress towards realizing our vision.

• Become the domain expert on KUB (Kidney Ureteral Bladder) anatomy, kidney stone standard of care treatments, and clinical procedure
• Utilize 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 novel procedural techniques, 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 to develop bench models and metrics for evaluation of prototypes designs 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

• A bachelor's degree in engineering (e.g. Biomedical, Mechanical) is required.
• An advanced degree (Masters, PhD, MD) is an asset.
• Any of the following combinations of education and experience is required; A.) Undergraduate degree with a minimum of 5 years of related work experience in medical device industry OR B.) Master’s with 4 years of related work experience in medical device industry OR C.) a PhD with 2 years of related work experience in medical device industry
• Experience collaborating with physicians to gather clinical performance feedback and identify unmet needs is required.
• 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. is essential.
• Experience designing and conducting pre-clinical engineering studies to assess product performance and safety is required.
• A proven proficient ability in identifying potential clinical risks and conducting thorough clinical harm analyses to enhance patient safety and product reliability is required.
• Experience developing Design Validation strategy, protocol creation and testing is required.
• Experience constructing customer and engineering design requirements is required.
• A proven ability to draw conclusions and make recommendations based on technical and clinical inputs from multiple and varied sources is required.
• Knowledge of endoscopic, laparoscopic procedures and operating room workflow is beneficial.
• Familiarity with fundamental concepts in surgical robotics is beneficial.
• Strong knowledge of relevant regulations and standards for medical devices and robotic surgery platforms, including FDA regulations and guidance, and IEC and ISO standards is an asset.
• Demonstrated success in leading and delivering complex projects from inception to completion is preferred.
• The willingness and ability to travel up to 15% of the time, internationally and domestic is expected.

• Generous vacation policy
• Commute assistance (Daily shuttle from SF, public transit stipend)

The anticipated base pay range for this position is 121,000 - 194,350 California Bay Area

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through innovative programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love! At Johnson & Johnson, we offer a variety of outstanding health and financial benefits, including competitive compensation, 401k, pension, medical, dental, and vision insurance, exercise reimbursement, flexible time off, paid volunteer and parental leave, and more! For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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 & 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,  external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

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