Systems Engineer

About you:

Vital Biosciences is seeking a Systems Engineer with experience in the field of in-vitro diagnostics to work on a path-breaking product. This role will be responsible for translating high-level product and user requirements into detailed technical specifications, ensuring a robust and compliant system architecture, and performing risk and impact analysis to support design and regulatory decisions. The ideal candidate will have a strong multi-disciplinary engineering background and experience in medical devices or IVD systems development.

What you will be doing:

1. Requirements Translation & System Design

• Translate product-level and user requirements into clear and actionable technical specifications for engineering teams.

• Define and maintain system-level design inputs that align with regulatory, usability, and performance requirements.

• Ensure technical specifications are traceable to user needs and regulatory standards (e.g., ISO 13485, IEC 62304, FDA 21 CFR 820).

2. System-Level Design & Cross-Disciplinary Coordination

• Develop and maintain system architecture documentation, ensuring alignment across hardware, software, mechanical, and assay disciplines.

• Serve as a technical liaison between R&D, software, mechanical, electrical, and assay teams to ensure seamless integration.

• Support design reviews, system modeling, and prototype evaluations.

3. Risk Management & Regulatory Compliance

• Lead and execute system-wide risk analysis activities (e.g., FMEA, Fault Tree Analysis, Hazard Analysis) to proactively identify and mitigate potential failures.

• Ensure system design and risk assessments comply with IVD regulatory requirements such as ISO 14971 (Risk Management for Medical Devices).

• Collaborate with Quality Assurance and Regulatory Affairs teams to support submission documentation.

4. Change Impact Analysis & Design Evolution

• Conduct impact analysis for proposed design changes, ensuring that modifications are assessed for potential risks and unintended consequences.

• Work with cross-functional teams to implement design changes while maintaining system integrity and compliance.

• Continuously refine system-level documentation to reflect the latest design decisions and risk assessments.

What you will need:

• Bachelor’s or Master’s degree in Systems Engineering, Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a related field.

• 5+ years of experience in systems engineering within the IVD, medical device, or life sciences industry.

• Strong understanding of systems engineering principles, risk management (ISO 14971), and design controls (ISO 13485, FDA 21 CFR 820).

• Experience with requirements management tools and risk analysis methods (FMEA, FTA, etc.).

• Ability to bridge gaps across disciplines (e.g., hardware, software, mechanical, and assay) and ensure holistic system integration. Demonstrated comfort level across these disciplines in previous tenures a strong positive

• Strong problem-solving skills and ability to work in a regulated, high-compliance environment.

Preferred:

• Experience in IVD assay development and liquid handling systems.

• Familiarity with IEC 62304 (Medical Software Development) and ISO 60601 (Electrical Safety Standards).

• Knowledge of Model-Based Systems Engineering (MBSE) or simulation tools.

• Experience in agile or phase-gated product development methodologies.

About Vital

Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.

Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth-minded culture empowers front-line decision-making and fosters impactful work.

We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.

Vital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance.