Systems Engineer
5 days ago
At Quest Global, it's not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.
Role Overview
We are seeking a Systems Engineering Contractor with strong technical and documentation skills to support the design and development of software systems in a regulated medical device environment. The ideal candidate will have experience in microservices architecture, systems documentation, and a solid understanding of medical product standards
Key Responsibilities
- Collaborate with cross-functional teams to define system requirements and architecture.
- Develop and maintain system-level documentation, including requirements specifications, design descriptions, and traceability matrices.
- Support the design and integration of microservices-based solutions within the system architecture.
- Ensure compliance with relevant medical device standards (e.g., IEC 62304, ISO 13485, ISO
- Participate in risk analysis, verification, and validation activities.
- Provide technical input during design reviews and audits.
We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every industry we reach. Our teams regularly invest time and dedicated effort into internal culture work, ensuring that all voices are heard.
We wholeheartedly believe in the diversity of thought that comes with fostering a culture rooted in respect, where everyone belongs, is valued, and feels inspired to share their ideas. We know embracing our unique differences makes us better, and that solving the worlds hardest engineering problems requires diverse ideas, perspectives, and backgrounds. We shine the brightest when we tap into the many dimensions that thrive across over 21,000 difference-makers in our workplace.
Work ExperienceRequired Qualifications
- Bachelor's degree in Systems Engineering, Computer Science, or related field.
- Proven experience in systems engineering for complex software systems.
- Working knowledge of microservices architecture and related technologies.
- Strong documentation and technical writing skills.
- Familiarity with medical device regulations and standards (IEC 62304, ISO 13485, ISO
- Ability to work independently and manage multiple priorities.
Preferred Skills
- Experience with requirements management tools (e.g., DOORS, Jama).
- Knowledge of cloud-based architectures and containerization (Docker, Kubernetes).
- Understanding of cybersecurity requirements for medical devices.
Key Performance Indicators (KPIs)
- Documentation Quality: 100% compliance with internal and regulatory documentation standards.
- Timely Deliverables: Completion of assigned system documentation and design artifacts within agreed timelines.
- Traceability: Full traceability between requirements, design, and verification artifacts.
- Compliance: Zero major findings in audits related to system documentation or standards adherence.
- Collaboration: Positive feedback from cross-functional teams on communication and technical contributions.
Deliverables
- System Requirements Specification (SRS) and System Architecture Document.
- Interface Control Documents (ICDs) for microservices-based components.
- Traceability Matrix linking requirements to design and test cases.
- Risk Analysis Documentation in compliance with ISO 14971.
- Verification and Validation Plan for system-level testing.
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