Biomedical Systems Engineer

4 weeks ago

Edmonton, Alberta, Canada Aversan Full time
Job Title: Biomedical Systems Engineer

Aversan, Inc. is a reputable engineering company that provides expertise in the aerospace and defense industries. We are currently seeking a qualified Biomedical Systems Engineer for our client, a fast-growing disruptive medical device startup company.

Responsibilities:
  • Providing technical leadership and oversight of diverse, distributed teams of engineers in development of complex medical device software, optics, electronics, mechanics, and machine learning from concept initiation to product release.
  • Translating customers' unmet needs into actionable user and system technical-level requirements, supporting platform architectures, and associated project execution plans.
  • Translating highly technical analysis to easily understood recommendations and design alternatives that will influence senior stakeholders.
  • Work across multidisciplinary teams to create, verify, manage, and track system- and subsystem-levels of requirements and specifications.
  • Demonstrating leadership and advanced knowledge of PLC, and SDLC methodologies.
  • Plan and oversee tasks breakdown and execution within the projects' teams, designated projects, and account for the project development execution in quality and on time.
  • Work with development teams to support risk analysis, risk management, FMEAs, and identify proper risk mitigation solutions to the system and subsystems.
  • Provide technical leadership in system integration, testing, verification, problem solving, and improvements.
  • Oversee and be deeply acquainted with development processes regulated by relevant standards, such as applicable medical device safety, risks management, usability, etc.
  • Overseeing systems design and documentation meet all safety and regulatory compliance.
  • Hands-on work on the system driving new functionality.
  • Attend animal and bench-testing labs for both R&D hands-on and/or clinical observations as part of clinical expertise required for system characterization.
  • Support key processes in the development life cycle, such as sustainability, failure investigations, SW optimization, technical experiments, risk management process, usability validation, and UI/UX specifications.
  • Provide technical leadership and guidance to the development team, ensuring adherence to best practices, and architectural principles.
Qualifications:
  • B.Sc. or M.Sc. from a known institute in the fields of: Biomedical, electrical, software, robotics, algorithms, or Systems engineering.
  • Experience through full product development cycle of complex medical device systems, or other regulated fields, from initial concept to product release.
  • Demonstrated technical leadership and ownership.
  • Proven ability of analytical problem solving and troubleshooting.
  • Ability to provide guidance and direction to less experienced technical personnel.
  • Track record of strong cross-functional collaboration, influence without authority, and project management enabling highly effective project teams.
  • Self-driven, Can-Do attitude.
  • 3+ years of hands-on technical/+ development experience (Electrical/SW/Biomedical/mechanical/robotics/optics).
  • Experience in leading a cross-functional technical challenge.
  • Great team player with engagement creation skills.
  • Fluent in technical English – verbal & written.
  • Ability for travel up to 20% of the time.
Nice to Haves:
  • 2+ years of work experience as a technical team leader or system Eng. in medical devices or other highly regulated industries – big advantage.
  • System engineering of a complex medical device experience – big advantage.
  • SW/HW/Algo characterization and requirements writing – big advantage.
  • Development experience in a regulated environment – advantage.
  • System performance modeling, simulation, and test (python, MATLAB...) -advantage.
  • Global company experience - advantage.
  • Image processing background - advantage.

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