Engineer, Analysis/Systems Engineering - Edmonton, AB, Canada - PulseMedica

Description

PulseMedica , recently Great Place to Work certified, is a fast growing disruptive medical device startup company. We combine research , innovation and production environments. We are determined to reduce ophthalmic disease and disability by offering novel treatment options using SOTA technologies.
Our platform combines real-time classical computer-vision and deep-learning algorithms, 3D eye imaging and high precision laser surgery platform.

Our goal is to revolutionize ophthalmic treatments by providing people with exceptional outcomes and, ultimately, changing the world by preventing blindness and disability resulting from eye diseases.

The Opportunity

As the Systems Engineer , you are an experienced and forward-thinking leader who will serve as the technical design leader for product developments and spearhead the definition and execution of system architecture.

Leading the system design, architecture, and vision, you will guide the development, integration, and testing phases of cutting-edge medical devices for development and productization.

You will provide technical guidance to a cross-functional engineering team that spans optics, mechanical, electrical, software and machine learning domains.

You will ensure the delivery of essential technical content to demonstrate performance, safety, regulatory compliance, operational efficiency, intellectual property, and QMS compliance.

Your influence will be crucial in achieving exceptional quality and alignment between business goals, system requirements and technical implementation. Your expertise in software, electronics, and systems engineering will be essential to ensure the successful delivery of our products.

The person will be responsible for:

Providing technical leadership and oversight to diverse, distributed teams of engineers in the development of complex medical device software, optics, electronics, mechanics, and machine learning from concept initiation to product release.

Translating unmet needs into actionable user and system technical-level requirements, supporting platform architectures, and associated project execution plans.
Translating highly technical analysis into easily understood recommendations and design alternatives that will support decision making by stakeholders.
Collaborating across multidisciplinary teams to create, verify, manage, and track system- and subsystem-level requirements and specifications.
Demonstrating leadership and advanced knowledge of PLC and SDLC methodologies.

Planning and supervising task breakdown and execution within project teams, ensuring projects are high quality and delivered on time.

Working with development teams to support risk analysis, risk management, FMEAs, and identifying proper risk mitigation solutions for systems and subsystems.

Overseeing development processes to ensure compliance with relevant standards, including medical device safety, risk management, and usability.
Ensuring systems design and documentation meet all safety and regulatory compliance requirements.
Engaging in hands-on work to drive new functionality within the system.

Participating in animal and bench-testing labs for both R&D hands-on work and clinical observations as part of clinical expertise required for system characterization.

Supporting key processes in the development life cycle, including sustainability, failure investigations, software optimization, technical experiments, risk management, usability validation, and UI/UX specifications.

Providing technical leadership and guidance to the development team, ensuring adherence to best practices and architectural principles.


Qualifications:
Minimum of Bachelor's degree in Biomedical, Electrical, Software, Robotics, Algorithms, or Systems Engineering.

Minimum of 3 years of hands-on technical and development experience in Biomedical, Electrical, Software, Robotics, Mechanical, or Optics fields.

Experience overseeing the full product development cycle of complex medical device systems or other regulated fields, from initial concept to product release.

Ability to provide guidance and direction to less experienced technical personnel.
Track record of strong cross-functional collaboration, influencing without authority, and project management enabling highly effective project teams.
Proven analytical problem-solving and troubleshooting skills.
Self-driven with a proactive attitude and a capacity to initiate tasks.
Collaborative team player with strong communication and engagement skills.
Must be located in Edmonton or willing to travel to Edmonton on a regular basis.

Preferred

Qualifications:

Minimum of 2 years of leadership experience in technical teams or as a Systems Engineer in medical devices or other highly regulated industries.

Experience in systems engineering of complex medical devices.
Proficiency in software, hardware, and algorithm characterization and requirements writing.
Proficiency in system performance modeling, simulation, testing, and image processing, using tools like Python, MATLAB, etc.

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