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Job Description & How to Apply Below
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
Solid analytical and communication skills
Enhance device safety and efficacy while directly contributing to impactful healthcare solutions with your expertise.
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