Summary
Overview
Work History
Education
Skills
Timeline
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Brett McKenzie

San Francisco,CA

Summary

Accomplished Clinical Research Engineer with a proven track record at Intuitive, specializing in the development of minimally invasive surgical platforms and robust training programs. Expert in GUI and digital interface development, and a skilled mentor, I excel in transforming clinical needs into innovative solutions. Demonstrated success in regulatory submissions and customer-focused training.

Overview

13
13
years of professional experience

Work History

Staff Clinical Research Engineer

Intuitive
04.2023 - Current
  • Drive the clinical aspects of capital system and user interaction development for next generation minimally invasive platform
  • Foster partnerships with multiple KOLs from world leading institutions via ongoing labs and on site visits to uncover clinical needs and evaluate early prototypes.
  • Collaborate daily with hardware and software engineers, UX designers, human performance engineers, clinical affairs, and regulatory to establish safe and effective functionality of our products from concept to functioning prototypes.
  • Mentor teammates to establish clinical engineering expertise (surgical skills, procedure expertise, clinical risk analysis, test method development) for new clinical specialty to Intuitive

Senior Clinical Development Engineer

Intuitive Surgical Inc.
08.2019 - 03.2023
  • Leveraged deep clinical, surgical, and technical skills as lead clinical engineer on multiple advanced development projects within the da Vinci Xi system, working with a small team for prototype optimization and surgeon evaluation.
  • Analyzed risk and optimized testing strategy as lead CDE for expansion of Intuitive's 3D anatomical visualization service.
  • Learned new surgical specialty to help procedure development and surgeon training ahead of clinical study for robotic indication expansion.
  • Senior member of Stapling CDE team. Mentored three teammates through challenges on their individual projects.

Clinical Development Engineer

Intuitive Surgical Inc
11.2014 - 08.2019
  • Led clinical development of the SureForm Stapler architecture from initial concepts through the launch of the device.
  • Worked closely with Mechanical and Software engineers, UX, HF, marketing, clinical affairs, regulatory, and quality to ensure product
  • Successfully executed clinical risk analyses, prototype development and design validation testing, regulatory submission & additional information request in support of the Sureform 60 regulatory submission.
  • Extensive pre-clinical model testing including human cadaver, acute and chronic animal studies.
  • Along with product marketing, designed and executed a surgeon preference evaluation (SPE) for the Sureform Stapler 60 instrument and reloads in Europe and the US
  • Performed in-service training for five general and bariatric surgeons and their OR staff on the Sureform 60 device during the SPE
  • Interviewed surgeons and led labs with customers from a variety of surgical backgrounds throughout the development of Sureform 60.
  • Drove the development, design validation testing, and launch of the previous generation EndoWrist Stapler 30, and participated in validation / launch activities of the EndoWrist Stapler 45.

Development Engineer I & II

Smith & Nephew
09.2011 - 10.2014
  • Collaborated with cross functional core team members to develop the SUTUREFIX Ultra suture anchor, a clinically successful instability repair device.
  • Provided clinical and technical expertise in training our sales force, both domestic and international, at our global sales meeting.
  • Supported initial surgical cases during the initial launch of the SUTUREFIX Ultra suture anchor.
  • Performed competitive product testing and analysis and worked with Marketing to provide evidence for product claims
  • Gathered feedback from KOLs and advisory board members in cadaver evaluations throughout the development of the device.
  • Attended a number of cases as well as various industry meetings, tradeshows, and training events while learning the clinical applications of our devices.

Education

Bachelor of Science - Biomedical Engineering

Boston University
Boston, MA
2011

Skills

  • Customer needs identification
  • GUI and Digital interface development
  • Robotic systems, instruments, and surgical training
  • Extensive market research and OR experience
  • Customer In-service training and launch support
  • Strong presenter and communicator
  • Collaborator and mentor
  • Competitive product analysis
  • Design controls
  • Regulatory Submission support
  • Technical writing
  • Microsoft Office

Timeline

Staff Clinical Research Engineer

Intuitive
04.2023 - Current

Senior Clinical Development Engineer

Intuitive Surgical Inc.
08.2019 - 03.2023

Clinical Development Engineer

Intuitive Surgical Inc
11.2014 - 08.2019

Development Engineer I & II

Smith & Nephew
09.2011 - 10.2014

Bachelor of Science - Biomedical Engineering

Boston University

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