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Clinical Systems Engineer

3 months ago

Edmonton, Alberta, Canada Aversan Full time

Aversan, Inc. is a distinguished engineering firm specializing in the aerospace and defense sectors. We are currently in search of a skilled Systems Engineer for our client, a rapidly expanding and innovative medical device startup recognized as a Great Place to Work for two consecutive years.
The Systems Engineer will possess robust technical leadership skills to guide our exceptional teams across various fields, including optics, mechanical, electrical, software, and machine learning. As a central figure in our initiatives, you will be instrumental in offering technical direction throughout the complete development lifecycle, which encompasses planning, design, implementation, and maintenance phases.

Key Responsibilities:
  • Delivering technical leadership and supervision of diverse, distributed engineering teams in the development of intricate medical device software, optics, electronics, mechanics, and machine learning from concept initiation to product launch.
  • Converting customers' unmet needs into actionable user and system-level technical requirements, supporting platform architectures, and associated project execution strategies.
  • Translating complex technical analyses into easily comprehensible recommendations and design alternatives that will impact senior stakeholders.
  • Collaborating across multidisciplinary teams to create, verify, manage, and track system and subsystem-level requirements and specifications.
  • Exhibiting leadership and advanced knowledge of PLC and SDLC methodologies.
  • Planning and overseeing task breakdown and execution within project teams, ensuring quality and timely project development execution.
  • Collaborating with development teams to facilitate risk analysis, risk management, FMEAs, and identifying appropriate risk mitigation strategies for systems and subsystems.
  • Providing technical leadership in system integration, testing, verification, problem-solving, and enhancements.
  • Ensuring that systems design and documentation comply with all safety and regulatory standards.
  • Engaging in hands-on work on the system to drive new functionalities.
  • Participating in animal and bench-testing labs for both R&D hands-on and/or clinical observations as part of the clinical expertise required for system characterization.
  • Supporting essential processes in the development lifecycle, such as sustainability, failure investigations, software optimization, technical experiments, risk management processes, usability validation, and UI/UX specifications.
  • Providing technical guidance and mentorship to the development team, ensuring adherence to best practices and architectural principles.


Qualifications:
  • B.Sc. or M.Sc. from a recognized institution in Biomedical, Electrical, Software, Robotics, Algorithms, or Systems Engineering.
  • Experience throughout the complete product development cycle of complex medical device systems or other regulated fields, from initial concept to product launch.
  • Demonstrated technical leadership and ownership capabilities.
  • Proven analytical problem-solving and troubleshooting skills.
  • Ability to provide guidance and direction to less experienced technical personnel.
  • Strong track record of cross-functional collaboration, influencing without authority, and project management to enable highly effective project teams.
  • Self-motivated with a proactive attitude.
  • 3+ years of hands-on technical development experience in Electrical, Software, Biomedical, Mechanical, Robotics, or Optics.
  • Experience in leading cross-functional technical challenges.
  • A collaborative team player with skills in engagement creation.
  • Fluent in technical English, both verbal and written.
  • Willingness to travel up to 20% of the time.


Preferred Qualifications:
  • 2+ years of experience as a technical team leader or systems engineer in medical devices or other highly regulated industries.
  • Experience in system engineering of complex medical devices.
  • Proficiency in software/hardware/algorithm characterization and requirements documentation.
  • Development experience in a regulated environment.
  • Experience in system performance modeling, simulation, and testing (Python, MATLAB).
  • Experience in a global company.
  • Background in image processing.