Sr. Clinical Engineer – Digital
Verb Surgical – A Google and Johnson & Johnson joint venture!
Verb Surgical is looking for a high-energy, results-oriented, and innovative engineer to join the Clinical Engineering team. A Clinical Engineer works closely with designers, engineers, and medical professionals from concept, through development, to commercialization. Our Clinical Engineer, Digital will drive collaboration across cross-functional teams to define clinical requirements, evaluate key technologies and product features, and lead clinical applications to advance Digital Surgery. We look for organized and accountable individuals with prior experience in digital health, user-experience design, pre-clinical, and pre-market development. The successful candidate excels at applying their deep technical expertise to real-world clinical use-cases in order to build a user-centric digital surgery experience. If you are driven to innovate at the intersection of digital health and surgical intervention, have excellent technical knowledge, and enjoy collaborating with medical professionals and engineers, then this could be right for you!
1. Key Opinion Leaders/Key Stakeholder Engagement
Work with Key Opinion Leaders to gain clinical knowledge and translate user needs to engineering development teams
Drive user-centric product vision to ensure successful integration with existing clinical workflows in a real world environment
Establish partnerships with clinical and non-clinical stakeholders in order to evaluate, iterate, and build the Digital Surgery foundation
2. Preclinical Tests and Studies
Identify clinical risks, define protocols, and execute user studies to drive development of an excellent Digital Surgery experience for stakeholders
Analyze user feedback and provide clinical input to user experience design team ensuring Digital features and workflow meet clinical user needs
Partner closely with cross functional teams, including R&D, marketing, and professional education, to build positive professional relationships across the organization and align on product definition
Manage protocols and test materials for cadaver studies and animal studies
3. Clinical Input for Regulatory Submission
Track clinical feedback and tie information into regulatory and quality documents, e.g. FMEA (Failure Mode Effects Analysis), risk analysis, hazard identification, use cases, and quality control plans
Lead clinical risk management discussions within project teams, ensuring risks have appropriate mitigation and contingency plans
Prepare and conduct design validation studies for customer requirements
Experiences and Qualifications (include Years of Experience, Leadership, Industry, etc.)
Master’s / PhD in a biosciences or engineering discipline.
3+ years of industry experience in the biotechnology or medical device industries
Expertise in digital health and user interfaces design and development
Knowledge of basic anatomy, surgery terminology, and surgical procedures
Experience developing combined hardware & software medical device.
Exceptional interpersonal and communication skills to build relationships internally and externally, with our corporate sponsors and with clinicians
Ability to produce and present clear, concise, and professionally written communications, graphics, and presentations
3+ years of experience in preclinical setting or regulated medical device development (executing preclinical studies, first in human studies and IDE studies experience are a plus)
Experience with and/or knowledge of FDA submission and approval processes preferred
Experience in an operating room environment
Experience in Human Factors Engineering/Human Factors Validation
Experience User Interaction/User Experience design
Who is Verb Surgical?
Verb Surgical™ is shaping the future of surgery. A new future, a future unimagined even a few years ago, which will involve machine learning, robotic surgery, instrumentation, advanced visualization, and data analytics. A future of surgery that aims to achieve improved patient outcomes, lower costs, and greater hospital efficiency.
Verb Surgical was founded with technology, expertise, and funding from Verily (formerly Google Life Sciences) and Ethicon, a medical device company in the Johnson & Johnson family of companies. This company will continue in strong partnership with Verily and Johnson & Johnson (Google and Johnson & Johnson Team for Robotic Surgery) to advance the surgical tools and capabilities available to surgeons and OR professionals today.