Join Neko Health as a Senior System Verification Engineer to ensure the safety and compliance of innovative health software products.
Posted by employer 1 month ago
First seen on Joblaze 1 month ago
Last verified on the company career page 1 day ago
Skills & Technologies
AI in the day-to-day
Experience using AI tools and agents in your own work.
Requirements
Not disclosed in this posting: compensation, work arrangement, visa sponsorship.
Joblaze summary
In the role of Senior System Verification Engineer at Neko Health, the individual is responsible for overseeing the system-level verification of health software products, ensuring they meet safety and performance standards. Key skills include expertise in test automation, programming fluency, and a solid understanding of regulatory requirements for software in a medical context. This position is ideal for someone with over five years of experience in regulated software verification, particularly in SaMD, who is looking to influence engineering quality in a fast-paced, growing team.
Joblaze insights
Quick facts
From the original posting
Our software informs clinical decisions, and we develop it with AI tools at the centre of the workflow. Traditional verification, with late manual test cycles and document-heavy handovers, can't keep up. You'll rethink how system-level verification of SaMD and health software works in this environment, and put it into daily use with Engineering, Quality and Regulatory. You'll join our growing, fast-moving Verification and Validation team.
Define how we verify health software at system level: what is tested, where, by whom, and with what evidence.
Build verification into AI-driven development, not bolt it on afterwards.
Evaluate and adopt tools and AI agents for test design, automation, impact assessment and evidence generation, based on what works.
Decide where an automated check is enough and where human review is needed, and make sure wrong calls are caught and fed back.
Turn requirements into test methods and acceptance criteria and push back when a requirement isn't testable.
Make traceability and audit-ready evidence a by-product of the work, not a separate task.
Keep us compliant with IEC 62304, ISO 14971, IEC 82304-1, ISO 13485, EU MDR and FDA 21 CFR Part 820, and help engineers find the fastest compliant route.
Must-have:
7+ years verifying software, with at least 3–4 of those in a regulated industry, ideally recently. SaMD or health software is ideal, but automotive, aerospace or GxP experience also works if you can learn the medical standards quickly.
Judgement from experience: you know which processes, tools and ways of working create confidence and which only create paperwork.
You have integrated verification into development and release pipelines (CI/CD).
You understand test automation well enough to direct, review and improve it.
You're comfortable with code and repositories, and you use AI tools in your own work.
You can create audit-ready V&V plans, traceability matrices and reports.
Nice to have:
Having built a test automation framework from scratch.
Having designed a verification process or toolchain in a regulated setting.
Verifying ML-based or algorithmic software.
Verifying software across cloud and mobile.
Experience with FDA submissions, EU MDR technical files or Notified Body audits.
Experience with embedded verification, on products where software runs on specific hardware.
Our software portfolio is growing faster than manual verification can scale, and it carries clinical decisions: what a member is told about a mole, a blood pressure reading or a heart signal. As a Senior System Verification Engineer, Software you build the verification that makes those answers trustworthy, and the automation that keeps it fast enough to ship frequently/regularly.
Standard company text repeated across Neko Health's postings is omitted here.