Sr. Clinical Engineer (digital)

South Bay, CA

Posted: 12/07/2018 Employment Type: Direct Hire Industry: Medical Device Job Number: JOS000008195

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


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.)
 
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

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