Senior System Engineer

Senior Systems Engineer

Burnaby, BC

Company Overview

Our client is a leading global medical device company dedicated to advancing patient care through innovative, high-quality products. Recognized for pioneering solutions in critical healthcare areas such as bladder volume measurement and airway management, the organization prioritizes clinical excellence, regulatory compliance, and continuous improvement. As part of a larger multinational corporation, the company operates across North America, Europe, and Asia Pacific, with a commitment to elevating standards of care worldwide.

Overview

We are seeking a Senior Systems Engineer to join our client’s R&D team in Burnaby, British Columbia. This role is pivotal in driving the technical definition and system architecture of cutting-edge medical devices, ensuring alignment with user needs and regulatory requirements.

Responsibilities

• Lead requirements development and verification processes, ensuring compliance with FDA and other regulatory standards.
• Develop systems architecture documentation to define subsystems, interfaces, and integration strategies.
• Facilitate risk assessments, including FMEA, to mitigate system-level risks.
• Manage product requirements traceability using industry-standard tools.
• Collaborate with cross-functional teams (clinical, marketing, engineering) to translate user needs into technical specifications.
• Serve as the primary technical liaison across stakeholder groups during product development.
• Support validation / verification strategies and analyze design changes for existing products.
• Deliver project timelines, ensuring on-time completion of systems engineering deliverables.
• Mentor junior engineers and contribute to process improvements within Systems Engineering.

Qualifications