Systems Risk Engineer Focusing on Software Safety and Compliance, Burnaby

Step into a rewarding role as a Systems Risk Engineer, dedicated to enhancing safety in medical technology. Engage in a hybrid work model, collaborating on cutting-edge software and electrical systems.

In this role, you will play a significant part in the Quality Engineering team, providing insights into risk management for life-saving medical devices. Your focus will be on ensuring that design changes meet stringent safety standards while producing thorough documentation for regulatory approval. This position is vital to the successful launch of groundbreaking heart treatment technology.

Key Responsibilities:• Create design FMEA and ensure updates are maintained • Work with teams to identify safety risks and mitigations • Evaluate impact of design changes on safety profiles • Prepare risk documentation for regulatory submission • Analyze software vulnerabilities and impacts

Requirements:• Bachelor’s in Software, Electrical or Biomedical Engineering • At least 4 years experience in design roles • 3+ years experience in a regulated industry • Familiarity with ISO standards for medical devices • Strong analytical and communication skills

Enhance device safety and efficacy while directly contributing to impactful healthcare solutions with your expertise. #J-18808-Ljbffr