Senior Software Quality Engineer

About Hypervision Surgical

Hypervision Surgical is a spin‑out from King’s College London, founded by clinicians and experts in medical imaging and artificial intelligence. Using safe light alone, our mission is to equip surgeons with real‑time, AI‑driven tissue intelligence to improve precision and patient safety. We are pioneering the world’s first regulatory‑cleared real‑time intraoperative spectral imaging platform, combining on‑chip spectral sensing with high‑speed AI analytics at over 60 frames per second. Seamlessly integrating into existing surgical vision systems, our technology transforms standard cameras into intelligent, data‑rich tools, revealing anatomical, physiological, and pathological information beyond human vision. Certified for both open and minimally invasive surgery, our platform achieved UKCA certification and FDA clearance in 2025 under a newly established AI/ML product code, and was admitted into the FDA’s Safer Technology Program. With multi‑centre clinical evaluations underway and strategic partnerships with world‑leading technology and surgical manufacturers, including imec and ZEISS Ventures, Hypervision is shaping the future of data‑driven surgery.

The Role

We are seeking a Senior Software Quality Engineer to own and advance the quality engineering practice within our medical device software team. As our product matures and our release cadence grows, this role will bring rigour, automation, and structure to the way we test and release, and do it in a way that makes the team faster, not slower. You will join a compact, highly skilled engineering team and work closely with the software engineering team, and alongside project management, quality assurance and integration testing colleagues, to ensure that every release is clearly scoped and documented, robustly tested, and delivered on time. This is a role for someone who wants to build, not maintain, embedding strong regulatory‑compliant processes into our day‑to‑day development. You will have the opportunity to design and own the framework that connects R&D algorithm development to production software verification. You will drive integration and system‑level test automation into earlier stages of the development cycle, extend our existing CI/CD pipelines with broader coverage, explore ways to efficiently test using real‑world data, and create the dashboards and tooling that give the team and leadership visibility into quality and release status.

Key Responsibilities

• IEC 62304 Compliance & Process Ownership
• Champion IEC 62304‑compliant development practices across the software engineering team, embedding compliance into the way work is done.
• Review and improve existing documentation release processes, with a remit to automate manual steps and ensure consistent quality across releases.
• Maintain traceability between software requirements, design, test cases, and test evidence throughout the product lifecycle.
• Ensure change control is applied correctly to software modifications, with appropriate impact assessment and re‑verification.
• R&D to Software Handover & Equivalence Testing
• Own the formal handover process between R&D algorithm development and production software implementation.
• Define and implement an equivalence testing framework to verify R&D specifications are faithfully reproduced in product implementations.
• Software Anomaly Management
• Own the end‑to‑end software anomaly process: detection, triage, investigation, root cause analysis, resolution, and closure in the QMS.
• Lead CAPA (Corrective and Preventive Action) activities for significant software defects, producing documented root cause analysis and validated resolution evidence.
• Maintain anomaly records in a state that is always audit‑ready, with clear traceability from problem report through to verified fix.
• Test Automation & CI/CD Expansion
• Extend our existing CI/CD pipelines to incorporate industry‑standard automated quality gates, including code analysis, test coverage measurement, and automated equivalence verification against R&D specifications, improving both confidence and traceability across every build.
• Design and implement automated test frameworks for integration and system‑level testing.
• Identify and reduce manual steps in the release process, improving speed and repeatability.
• Improve pipeline visibility: build dashboards and reports that give the team and leadership real‑time insight into test status, coverage gaps, and release readiness.

At Hypervision Surgical, we welcome candidates who have the core skills for the role and are keen to learn and grow with us. We are committed to creating an inclusive environment where a diverse mix of talented people come together and enjoy working with one another. By working together, we will change the way surgery is performed and improve patient care.

About You

You are a delivery‑focused project manager who is comfortable operating in ambiguity, enjoys working closely with technical teams, and takes pride in enabling others to do their best work.

Experience

• 5 to 8 years in software quality engineering or software development within a regulated medical device environment.
• Familiarity with ISO 13485 QMS principles and document control.
• Hands‑on IEC 62304 experience; you have authored compliant software lifecycle documentation, not just reviewed them.
• Working knowledge of EU MDR software requirements or FDA 21 CFR Part 11.
• Proven ownership of software integration or system‑level test programmes.
• Experience implementing or extending Python‑based test automation frameworks.
• Experience managing software anomalies through to closure, including formal CAPA activities.
• Familiarity with risk management standards: ISO 14971 and their application to software.

Technical Skills

• Python proficiency; comfortable writing test harnesses, automation scripts, and data comparison tools.
• Ability to read and reason about C++ codebases: you do not need to write production C++, but you must be able to understand software architecture, follow code reviews, and design tests that exercise C++ components meaningfully.
• Understanding of image processing or numerical computing pipelines at a conceptual level, including how to define and validate equivalence between implementations.

Desirable Qualifications

• Experience with CI/CD tooling; extending and maintaining pipelines (e.g. GitHub Actions, GitLab CI, Jenkins, or equivalent).
• Familiarity with static analysis tools in a regulated context.
• Experience with a requirements management platform supporting full traceability, change control, and audit‑ready documentation (e.g. Helix ALM, Matrix Requirements, Polarion, or equivalent).
• Experience with image processing, computer vision, or GPU‑accelerated software.
• Background in scientific or numerical software testing: tolerance‑based equivalence, statistical validation, regression on computed outputs.
• Experience building quality dashboards using tools such as Grafana, Power BI, or custom Python/web‑based reporting.
• Familiarity with cybersecurity requirements for medical device software (IEC 81001‑5‑1 or equivalent FDA guidance).

Bonus points if you bring a special talent, interest, language, or unique life experience to the team.

What We Offer

• Access to state‑of‑the‑art surgical development facilities at St Thomas’ MedTech Hub, including hospitals, operating rooms, labs, and computational resources, with offices located at the London Institute for Healthcare Engineering.
• The opportunity to make a direct contribution to patient care and deliver real‑world surgical impact.
• Competitive salary.
• Equity participation via share option scheme.
• 25 days of annual leave plus bank holidays.
• Hybrid working arrangements, tailored with your manager to suit the needs of the role.
• Employee Assistance Programme for wellbeing, legal, and financial support.
• Cycle to Work Scheme and Workplace Nursery Benefits.
• £150 annual tech stipend for productivity and office essentials.
• Complimentary office snacks and drinks.
• Monthly team socials in an inclusive, collaborative culture.