Clinical Engineer

Johnson & Johnson • Santa Clara, CA

3d • Onsite

About The Position

Robotics and Digital Solutions, part of Johnson & Johnson MedTech family of companies, is recruiting for a Clinical Engineer for the Monarch Bronchoscopy 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 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 Bronchoscopy 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

• Hold a degree in engineering (e.g. Biomedical/Bioengineering, Mechanical, Electrical) and have 0-3 years of related experience in medical device development.
• 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 collaborating with physicians to gather clinical performance feedback and identify unmet needs 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.
• 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.

Nice To Haves

• An advanced degree (Masters) is preferred.
• 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 is required.
• Knowledge of endoscopic 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.

Responsibilities

• Become the domain expert on lung anatomy, standard of care treatments, and clinical procedures & workflows.
• 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 product launches and initial cases during customer site bring up

Benefits

• medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• consolidated retirement plan (pension) and savings plan (401(k)).
• Vacation –120 hours per calendar year
• Sick time - 40 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
• Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level