QA/RA Project Manager
DeepHealth
Systems Engineer
Vital Bio
full-time
Posted on:
Location Type: Office
Location: Oakville • 🇨🇦 Canada
Visit company websiteJob Level
Mid-LevelSenior
About the role
- 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).
- 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.
- Lead and execute system-wide risk analysis activities (e.g., FMEA, Fault Tree Analysis, Hazard Analysis).
- Ensure system design and risk assessments comply with IVD regulatory requirements such as ISO 14971.
- Collaborate with Quality Assurance and Regulatory Affairs teams to support submission documentation.
- Conduct impact analysis for proposed design changes, ensuring 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.
Requirements
- 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).
- Strong problem-solving skills and ability to work in a regulated, high-compliance environment.
- Preferred: Experience in IVD assay development and liquid handling systems.
- Preferred: Familiarity with IEC 62304 and ISO 60601.
- Preferred: Knowledge of Model-Based Systems Engineering (MBSE) or simulation tools.
- Preferred: Experience in agile or phase-gated product development methodologies.
Benefits
- 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.
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
systems engineeringrisk managementdesign controlsrequirements managementFMEAFault Tree AnalysisHazard AnalysisModel-Based Systems Engineeringagile methodologiesphase-gated product development
Soft skills
problem-solvingcollaborationcommunicationcross-functional teamworktechnical liaison
