Senior Quality Engineer

Neko Health is a Swedish healthcare technology company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Neko's vision is to shift healthcare from reactive treatment toward preventative health and early detection. This requires completely reimagining the patient's experience and incorporating the latest advances in sensors and AI.  Neko Health has developed a new medical scanning technology concept to make it possible to do broad and non-invasive health data collection that is convenient and affordable for the public. The company is based in Stockholm, offering the Neko Body Scan experience at locations in Stockholm, London and Manchester, with over 500 employees.  
About the Role
Location: Stockholm, Sweden or Europe | Full-time Remote or Hybrid 
At Neko Health, we develop innovative medical technologies that enhance healthcare outcomes. As a Senior Design Quality Engineer, you will ensure our medical device products meet regulatory and quality standards throughout development. You will drive design controls, risk management, verification & validation, and design transfer, ensuring compliance with ISO 13485, EU MDR, and FDA regulations.

Responsibilities:

• Improve and implement design control processes across the product lifecycle.
• Lead Risk Management, ensuring systematic identification and mitigation of risks, especially in software-driven and AI-enabled technologies.
• Oversee verification and validation strategies for both hardware and software.
• Ensure design changes are properly assessed, documented, and compliant.
• Support technical documentation for regulatory submissions (e.g., DHF, Technical Documentation).
• Facilitate design reviews, ensuring compliance with safety and usability requirements.
• Drive design transfer, collaborating with Manufacturing and Operations to ensure smooth production handover.
• Ensure process validation and production controls are in place for manufacturing quality.
• Act as a subject matter expert for internal and external audits related to design quality and design transfer.

Requirements:

• 5+ years of experience in Design Quality Engineering within the medical device industry.
• Expertise in ISO 13485, IEC 62304, IEC 62366, and risk management (ISO
• Experience with change management and design transfer to manufacturing.
• Strong understanding of hardware and software development for medical devices.
• Experience with Software as a Medical Device (SaMD) and AI/ML-based technologies.
• Skilled in cross-functional collaboration and problem-solving.
• Excellent written and verbal communication skills in English.
  

Nice to HaveKnowledge of cybersecurity requirements for medical devices.Experience with Notified Body interactions and regulatory submissions. Why Join Us?

• At Neko Health, you'll work in an innovative and collaborative environment, shaping the future of AI/ML-driven and software-enabled medical technologies, while ensuring regulatory compliance and efficient design transfer.
• If you're passionate about design quality, risk management, and compliance, we'd love to hear from you

About the Engineering Team
Distributed and Remote First We are nearly 100 full time engineers at the company, working from Berlin, Chamonix, Hamburg, Lisbon, Marseille, Vilnius, and Stockholm, spanning diverse disciplines such as Hardware Engineering, Firmware Development, Electrical Design, Algorithm Development, Machine Learning Development, Optronics Research, Frontend Development and more. We don't expect people to join us with a specific tech knowledge, but we do expect you to work with our tools. We use a mix of React, Typescript, C++, and Python. Our APIs are written in C# with ASP.NET Core, uses Azure Cosmos DB, and Azure Active Directory for authentication. 
Our headquarters and our hardware development team are in Stockholm, Sweden.
We are a Remote First company; however, it is of course much easier to work remotely as a software engineer than a hardware or firmware engineer (since they require access to hardware or devices occasionally). Software engineers based in Stockholm work maybe one day a week or one day every two weeks from the office.
We meet a couple of times per year to get to know each other and have fun.
Organization and Way of Working The engineering team is divided into smaller cross functional project teams that each focus on a specific goal or target, where some groups are long-lived, and some are short-lived, depending on how big the goal or deliverable is. We strive to create groups which are cross-functional and able to complete their goals without dependence on other teams, even though this is of course not always possible.
Groups track goals on a yearly and quarterly basis with goal follow-up across the entire engineering organization on a bi-weekly basis. Most groups do internal planning on a bi-weekly basis, but in the end it's up to the group to decide how they want to work.
We have, however, mandated that all groups must present their progress or failures or hacks at our bi-weekly engineering demo, a fun meeting/presentation where we talk about everything from short-circuiting power-modules, how hard it is to calibrate cameras or align polygons in space, to neat new command line tools for operations, a new auth mechanism in the backend, a cool new way to visualize health data or a new feature which helps our doctors be more productive.
We have a flexible workplace that focuses on work/life balance, and we strongly believe in our mission but do not think that achieving it requires sacrificing everything else. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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