Clinical Engineer

Mountain View, CA

Posted: 03/04/2019 Employment Type: Direct Hire Industry: IT Job Number: JOS000008195

This company 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! 
 
Key Responsibilities/Tasks:                     
 
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 

  1.  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 
  1.  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.) 
  
Required  

  • 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 

Preferred  

  • 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 

Travel:      10-20% 

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