Medical Device Quality Engineer

CoMind

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. THE ROLE: The Software Engineering team at CoMind spans the full stack of a regulated medical device company from embedded and real-time systems through application software, ML inference, GUI, DevOps, and test engineering. It is a team that builds across every layer, working to medical device software standards and shipping software that has to perform reliably in clinical environments. As a Senior/Staff Software Test Engineer, you will define the quality and verification strategy across CoMind’s entire software stack from embedded real-time systems to cloud-side data pipelines. You will move beyond task-level execution to architect the infrastructure and 'compliance-as-code' processes that provide the engineering team with high-velocity, high-confidence validation. You will serve as a key technical authority, ensuring our software not only meets stringent IEC 62304 and ISO 14971 standards but does so through sustainable, automated design. You will function as the technical authority for software quality. Your goal is to move CoMind beyond traditional V&V, architecting a self-validating system that integrates safety, regulatory compliance, and high-velocity development. You will be the bridge between Systems Engineering, Regulatory Affairs, and Software Engineering, ensuring that quality is an inherent attribute of our technology rather than a post-development checklist. At CoMind, all team members work at least 4 days per week in the office, plus a flexible work-from-home day. This role is based in our London (Kings Cross) office. RESPONSIBILITIES: * Architect a scalable, high-fidelity testing infrastructure that enables continuous validation. Champion 'design for testability' across the entire engineering stack, influencing system architecture to ensure critical safety and performance requirements are verifiable by design. * Define the end-to-end V&V strategy for the product lifecycle. Quantitatively map software verification evidence directly to system-level safety risks (ISO 14971) to create a 'compliance-as-code' environment that drastically reduces time-to-submission for FDA and other regulatory bodies. * Drive a 'quality-first' engineering culture by mentorship. Lead training and initiatives on Test-Driven Development (TDD), CI/CD best practices, and automated quality gates, ensuring that the engineering team’s velocity is sustained by high-confidence automated processes. * Lead the development of AI-augmented test strategies. Architect predictive anomaly detection systems and AI-driven test generation engines that evolve alongside our software, turning the test suite into an intelligent system that learns from past regressions. * Collaborate with engineering leadership to drive continuous improvement in software development and test processes, ensuring that quality practices scale with the organisation. * 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. SKILLS & EXPERIENCE: * Strategic Execution: 7+ years in software test engineering, with a proven track record of architecting testing strategies for complex, regulated systems (embedded, real-time, or SaMD). * Regulatory & Risk Authority: Deep working knowledge of IEC 62304 and ISO 14971. Proven ability to design 'compliance-as-code' workflows that integrate risk controls directly into the CI/CD pipeline and automate regulatory evidence generation. * Technical Proficiency: Advanced Python and C/C++; extensive experience building scalable test infrastructure for both embedded hardware and cloud-side data pipelines. * Cultural Leadership: Demonstrated success in mentoring software engineers and driving a 'quality-first' culture through TDD, static analysis, and automated quality gates. * Cybersecurity & Documentation: Strong experience in cybersecurity requirements (e.g., IEC 81001-5-1, FDA cybersecurity guidance) and rigorous documentation management for regulatory submission. NICE TO HAVE * Experience testing real-time Linux or RTOS-based products. * Background in MLOps, including validation of model drift, dataset governance, and automated performance evaluation. * Expertise in managing complex build environments (e.g., CMake, Bazel) or cloud-native infrastructure-as-code (Terraform, AWS/GCP). * Direct experience navigating FDA Q-Sub or MHRA pre-submission processes. * Experience with hardware-in-the-loop or software-in-the-loop test environments. BENEFITS: * Company equity plan so all employees share in the success of the company * Salary-sacrifice pension scheme * Private medical, dental and vision insurance (medical history disregarded) * Group life assurance at 4x annual income * Comprehensive mental health support, including unlimited access to 1:1 sessions with trained professionals * Unlimited holiday allowance (+ bank holidays) and one week of remote working per quarter * Lunch voucher (£10) every day for JustEat and free dinner on those days where you need to work later * Twice weekly deliveries of fresh fruit and an extensive selection of snacks and drinks * YuLife subscription, allowing you to turn your daily steps and meditation into discounts at a range of stores DISCLAIMER - We use AI notetaking tools to transcribe interviews for internal review. By proceeding, you consent to this. Let us know if you'd prefer we don't.

CoMind

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. THE ROLE: The Product Assurance team at CoMind is responsible for ensuring the device performs as intended against its specified requirements, generating the test evidence needed to support regulatory submissions and design history files. Working across hardware, software, and integrated system levels, the team designs and executes test methods and protocols that demonstrate design outputs meet design inputs to the standard required for FDA clearance and CE marking. As a Verification Test Engineer, you will own the design and execution of V&V test activities for CoMind’s device, working across hardware, software, and system levels. You will develop test protocols, validate the test methods and equipment, execute testing, analyse and collate results, and author reports for a regulated medical device, working closely with systems engineering and quality throughout. As a member of the Product Assurance team the role reports into the Systems and V+V Manager. You will have a good scientific and engineering background with a rigorous and systematic approach to problem solving, product testing and product 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 is based in our London (Kings Cross) office. RESPONSIBILITIES: * Design, write, and execute test protocols for hardware, software, and system-level design verification testing * Develop and qualify test methods, test equipment and protocols against system and sub-system requirements * Collate and analyse test results, identify and report anomalies and non-conformances, and work with quality and engineering teams to investigate root causes and determine disposition * Author verification test reports to the standard required for design history files and regulatory submissions, including FDA clearance and CE marking * Maintain requirements traceability matrices, ensuring test coverage is complete and gaps are identified and resolved ahead of design reviews and regulatory milestones * Support system integration testing, coordinating test execution across hardware, firmware, and software components and documenting integration test outcomes * Contribute to risk management activities under ISO 14971, including review of FMEAs and verification of risk control effectiveness * Develop and maintain test infrastructure, fixtures, calibration status and tooling needed to execute verification activities efficiently and repeatably * 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 SKILLS & EXPERIENCE: * 4+ years of experience in verification, test engineering, or a closely related role, with hands-on experience writing and executing test protocols for complex hardware or software systems * Experience in a regulated industry (medical devices, aerospace, automotive, or similar) and design control requirements * Good analytical skills, with the ability to identify and investigate test anomalies, document non-conformances, and support root cause analysis * Experience in developing software based test tools and scripts in Python for collecting and analyzing test data * Familiarity with requirements management tooling and test management platforms * Clear and precise technical writing skills, with experience authoring test protocols and reports that meet regulatory documentation standards NICE TO HAVE: * Working knowledge of ISO 14971 and ISO 13485 applied to product design and development * Experience with hardware-in-the-loop or software-in-the-loop testing for embedded or real-time systems * Experience in optical, photonic, or biomedical hardware test and characterisation * Familiarity with IEC 62304 software V&V requirements and the interface between hardware and software test activities * Exposure to automated test frameworks or scripting for test automation in an embedded or mixed-signal context BENEFITS: * Company equity plan so all employees share in the success of the company * Salary-sacrifice pension scheme * Private medical, dental and vision insurance (medical history disregarded) * Group life assurance at 4x annual income * Comprehensive mental health support, including unlimited access to 1:1 sessions with trained professionals * Unlimited holiday allowance (+ bank holidays) and one week of remote working per quarter * Lunch voucher (£10) every day for JustEat and free dinner on those days where you need to work later * Twice weekly deliveries of fresh fruit and an extensive selection of snacks and drinks * YuLife subscription, allowing you to turn your daily steps and meditation into discounts at a range of stores DISCLAIMER - We use AI notetaking tools to transcribe interviews for internal review. By proceeding, you consent to this. Let us know if you'd prefer we don't.

CoMind

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. THE ROLE: The Software team at CoMind spans the full stack of a regulated medical device company — from embedded and real-time systems through application software, ML inference, GUI, DevOps, and test engineering. It is a team that builds across every layer, working to medical device software standards and shipping software that has to perform reliably in clinical environments. As a Staff Software Engineer, you will be a technical authority within the Software team, owning complex technical problems in embedded and real-time C++ development. You will work across hardware abstraction, real-time data acquisition, and system integration, bringing the depth of experience needed to architect and deliver software that performs reliably in a regulated, safety-critical context. At CoMind, all team members work at least 4 days per week from our new Kings Cross office, plus a flexible work-from-home day. RESPONSIBILITIES: * Design, implement, and maintain high-performance embedded and real-time software components in C++, including hardware abstraction layers, device drivers, and data acquisition pipelines. * Define and drive technical strategy, proactively identifying and mitigating cross-team dependencies and technical debt while setting the long-term vision for embedded architecture. * Act as a technical bridge, synthesising and communicating complex architectural decisions to non-technical stakeholders (including Product, Clinical, and Regulatory teams) to ensure alignment on project goals. * Mentor and grow engineers, fostering a culture of technical excellence, code quality, and professional development within the broader software team. * Ensure software quality through code review, unit and integration testing, and strict adherence to CoMind’s software development lifecycle under IEC 62304. * Collaborate with electronics and FPGA teams on hardware-software interfaces, supporting hardware bring-up, system integration, and complex debug. * Contribute to risk management and design documentation activities, including software hazard analysis and traceability in line with ISO 14971 and CoMind’s QMS. * Participate in design reviews, sprint planning, and cross-functional technical forums, contributing to a high-performance engineering culture. * 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. SKILLS & EXPERIENCE: * 10+ years of experience in software engineering, with a strong focus on systems-level software architecture * Deep expertise in modern C++ (C++17 or later), including memory management, concurrency, real-time constraints, and performance optimisation * Hands-on experience developing software for embedded Linux environments, including device driver development and hardware abstraction * Experience in a regulated industry (medical devices, aerospace, automotive, or similar) including familiarity with IEC 62304 or equivalent software development standards * Strong understanding of hardware-software integration, including FPGA or microcontroller interfaces, communication buses (SPI, I2C, UART, PCIe), and real-time operating systems * Demonstrated ability to write clean, well-tested, and maintainable code in a safety-critical context NICE TO HAVE * Experience with high-speed data acquisition systems or real-time signal processing pipelines * Familiarity with optical or biomedical hardware integration * Background in or exposure to data science or ML pipelines and the software interfaces that feed them * Experience with CI/CD tooling, automated testing frameworks, and static analysis tools in an embedded context * Knowledge of IEC 60601-1-4 or other medical device software standards * Familiarity with architecture and engineering of cloud-based IoT systems * Experience with health-tech data residency BENEFITS: * Company equity plan so all employees share in the success of the company * Salary-sacrifice pension scheme * Private medical, dental and vision insurance (medical history disregarded) * Group life assurance at 4x annual income * Comprehensive mental health support, including unlimited access to 1:1 sessions with trained professionals * Unlimited holiday allowance (+ bank holidays) and one week of remote working per quarter * Lunch voucher (£10) every day for JustEat and free dinner on those days where you need to work later * Twice weekly deliveries of fresh fruit and an extensive selection of snacks and drinks * YuLife subscription, allowing you to turn your daily steps and meditation into discounts at a range of stores