Senior Systems Engineer
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About the role
The Systems Engineering function at CoMind sits at the intersection of hardware, software, and clinical domains, responsible for defining and managing requirements and driving system-level architecture decisions, supporting product risk management activities and informing product integration and verification campaigns. As a member of the System and Product Assurance team the Senior System Engineer role reports into the Systems and V+V Manager. As the Systems Engineer, you will own requirements management, system-level design, and integration activities for CoMind's device. Working closely with product management and across hardware, software, optical, and regulatory functions you will ensure the system performs as intended in its clinical use environment. You will define and maintain the system architecture and requirements baselines, drive V&V planning and execution, and act as a technical integrator across the engineering team. The role will work closely with the product Risk Manager to ensure close integration of risk management activities with system design and integration. At CoMind, all team members work at least 4 days per week in the office, plus a flexible work-from-home day. This role can be based in either our London (Kings Cross) or Bristol office.
Responsibilities
- Define, manage, and maintain the system-level requirements baseline, ensuring traceability from design inputs through to subsystem specifications and test evidence
- Own system-level architecture documentation, capturing interfaces, design choices, and performance allocations across hardware, software, and optical subsystems
- Drive system integration activities, defining integration sequences, resolving cross-subsystem interface conflicts, and ensuring all interfaces are correctly specified and verified
- Lead V&V planning and execution at the system level, working with subsystem teams to ensure test coverage is complete and regulatory evidence is generated to the required standard
- Support design risk management activities under ISO 14971, including system-level hazard analysis, FMEA, and risk control verification
- Maintain and develop systems engineering processes and tooling, including requirements management platforms, design review structures, and traceability practices
- Represent the system architecture in cross-functional forums, supporting regulatory submissions and design history file activities
- AI is fundamental to our culture - it's not just a tool, but a core part of how we work, collaborate, and innovate. We expect all team members to embrace AI in their daily work and continuously find new ways to use it effectively
Requirements
- 5+ years of experience in systems engineering, with a track record of owning requirements management and system integration on complex, multi-domain products
- Experience with medical devices or other regulated industries, with working knowledge of IEC 60601-1, ISO 14971, ISO 13485, and design control processes
- Proficiency with requirements management tooling (DOORS, Jama, Polarion, or similar) and familiarity with model-based systems engineering approaches
- Demonstrated ability to manage and resolve cross-subsystem interface conflicts and drive system-level integration in a multi-disciplinary engineering environment
- Experience supporting V&V planning and execution at the system level, including generating and reviewing test protocols and reports to regulatory standards
- Strong written and verbal communication skills, with the ability to translate complex system-level decisions for clinical, regulatory, and executive stakeholders
- Background in photonics, optical sensing, or biomedical hardware systems
- Familiarity with IEC 62304 and the interface between hardware and software systems engineering
- Experience supporting FDA regulatory submissions, including design history files and 510(k) preparation
- Exposure to clinical trial environments and the interface between engineering and clinical teams
Benefits
Additional Information
At CoMind, we are developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring. In joining us, you will be helping to create cutting-edge technologies that will improve how we diagnose and treat brain disorders, ultimately improving and saving the lives of patients across the world.
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