Staff Clinical Engineer

Johnson & Johnson-posted 3 days ago

Full-time • Mid Level

Onsite • Santa Clara, CA

5,001-10,000 employees

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Staff Clinical Engineer Robotics and Digital Solutions, part of Johnson & Johnson MedTech family of companies, is recruiting for a Staff Clinical Engineer for the Monarch Urology team. This position is located in Santa Clara, CA. What We Do: 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! At J&J Robotics we're changing the trajectory of health for humanity, using robotics to enhance healthcare providers' abilities and improve patients' diagnoses, treatments, and recovery times. J&J 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, 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. 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 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 procedures
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 prototype 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 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

One of the following combinations of experience and education are required.
A.) A bachelor's degree in engineering (e.g. Biomedical/Bioengineering, Mechanical, Electrical) with a minimum of 8 years of related work experience in medical device development OR B.) A master’s degree in engineering (e.g. Biomedical/Bioengineering, Mechanical, Electrical) with a minimum of 6 years of related work experience in medical device development OR C.) A PhD/MD with a minimum of 4years of related work experience in medical device development
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 required.
Experience constructing customer and engineering design requirements is required.
Experience designing and conducting pre-clinical engineering studies to assess product performance and safety is required.
Proficient 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.
Ability to draw conclusions and make recommendations based on technical and clinical inputs from multiple and varied sources is required.
Outstanding problem-solving and analytical abilities, with a focus on identifying technical challenges and driving innovative solutions is required.
The willingness and ability to travel up to 15% of the time, internationally and domestic is required.

An advanced degree (Masters, PhD, MD) is preferred.
Knowledge of endoscopic, laparoscopic procedures and operating room workflow is preferred.
Familiarity with fundamental concepts in surgical robotics is an asset.
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 preferred.
Demonstrated success in leading and delivering complex projects from inception to completion is an asset.

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!
Perks Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

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