Senior Clinical Engineer - Monarch Urology

Johnson & Johnson•Santa Clara, CA

39d

About The Position

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.

Requirements

A bachelor's degree in engineering (e.g. Biomedical, Mechanical) is required.
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.
The willingness and ability to travel up to 15% of the time, internationally and domestic is expected.

Nice To Haves

An advanced degree (Masters, PhD, MD) is an asset.
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.

Responsibilities

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