overview

Senior Clinical Engineer

 

Position Summary

The Senior Clinical Engineer will be an integral part of the development process, focused on remote robotics, expanding clinical indications on the current commercial system, and other next-generation features. You will bring in-depth knowledge and experience in both pre-clinical and clinical environments. You will work closely with R&D engineers, upstream marketing, and clinical collaborators to help drive the definition, development, and validation of next-generation products and capabilities. Your primary focus is to help establish clinical requirements, identify risks, and validate that engineering solutions address them. The position requires direct contact with customers, including physicians, clinicians, and other hospital personnel. You will be integrated into teams at key development sites and expected to establish and maintain strong relationships and communication between Corindus personnel and development site teams.

Primary Responsibilities

  • Collaborate closely with upstream marketing and R&D to ensure successful completion of development initiatives and milestones
  • In collaboration is R&D, define, investigate, and test robotic vascular systems, subsystems, and prototypes; including simulated-use testing, pre-clinical/clinical testing, design validation testing, human factors engineering testing, and user questionnaires and surveys
  • Apply engineering and scientific principles to advance the effectiveness of clinical procedures and workflow through use of robotics, remote treatment capabilities, and artificial intelligence
  • Provide technical and clinical guidance to programs from concept to development to FDA submission based on clinical insights and extensive data analysis
  • Provide training on Corindus products and prototypes to internal and external customers according to the training and instructional manuals and protocols
  • Support formative and summative human factors testing, working with external partners and full facilitation of formative evaluations at clinicals sites
  • Support device regulatory submission activities, through use case development/validation and bench simulations
  • Support definition and validation of medical robotic procedures including: Instructions for Use, troubleshooting procedures, and training materials
  • Work closely with development partners in the clinical community to help drive development initiatives
  • Troubleshoot, diagnose, and repair prototypes and development systems, remotely and on-site
  • Analyze clinical and technical data to support product and prototype development and generate related reports

Desired Skills and Experience

Required

  • Bachelor’s degree in mechanical, bioengineering, biomedical engineering or clinical engineering required. Bachelor’s degree in biological/ clinical sciences acceptable with medical device development/ testing experience.
  • 5+ years in medical device field developing or testing medical devices. Advanced degrees may substitute for years of experience.
  • Understanding of and experience in the clinical/pre-clinical settings
  • Ability to plan, organize, and work independently, with minimal supervision
  • Capable of handling multiple high-priority projects at the same time
  • Understanding of medical terminology, specifically related to vasculature
  • Strong biomedical, electrical, mechanical or analytical aptitude
  • Excellent communication skills with the ability to balance customer relationships with company and project objectives
  • Strong clinical data skills with focus on analytics and statistics
  • Excellent interpersonal skills; ability to work in a cross-functional team environment
  • Ability to articulate complex technical ideas/information clearly, effectively, and persuasively
  • Experience in generating protocols, procedures, and engineering tests/reports
  • Ability to travel up to 50% of the time, occasionally on short notice

Preferred

  • Graduate degree with clinical or biomedical engineering concentration
  • Experience in clinical/pre-clinical settings
  • Experience with endovascular technologies and products in the cardiovascular and neurovascular spaces
  • Statistical software, such as MiniTab or SAS
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