Senior Quality Engineer - Design

Neko Health is a Swedish health-tech company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Our vision is to create a healthcare system that can help people stay healthy through preventive measures and early detection. Neko has developed a new medical scanning technology concept to make it possible to do broad and non-invasive health data collection that is both convenient and affordable for the public. This requires completely reimagining the healthcare experience and incorporating the latest advances in sensors and AI. We are a remote first company, but the company is based in Stockholm and has over 300 employees across Europe.

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 aSenior Design Quality Engineer, you will ensure our medical device products meetregulatory and quality standardsthroughout development. You will drivedesign controls, risk management, verification & validation, and design transfer, ensuring compliance withISO 13485, EU MDR, and FDA regulations.

Responsibilities:

Improve and implement design control processesacross the product lifecycle.

LeadRisk Management, ensuring systematic identification and mitigation of risks, especially insoftware-driven and AI-enabled technologies.

Overseeverification and validation strategiesfor bothhardware and software.

Ensuredesign changesare properly assessed, documented, and compliant.

Supporttechnical documentationfor regulatory submissions (e.g.,DHF, Technical Documentation).

Facilitatedesign reviews, ensuring compliance with safety and usability requirements.

Drivedesign transfer, collaborating withManufacturing and Operationsto ensure smooth production handover.

Ensureprocess validation and production controlsare in place for manufacturing quality.

Act as asubject matter expertfor internal and externalauditsrelated todesign quality and design transfer.

Requirements:

5+ years of experienceinDesign Quality Engineeringwithin themedical device industry.

Expertise inISO 13485, IEC 62304, IEC 62366, and risk management (ISO 14971).

Experience withchange management and design transferto manufacturing.

Strong understanding ofhardware and software developmentfor medical devices.

Experience withSoftware as a Medical Device (SaMD) and AI/ML-based technologies.

Skilled incross-functional collaborationand problem-solving.

Excellentwritten and verbal communication skills in English.

Nice to Have

Knowledge ofcybersecurity requirements for medical devices.

Experience withNotified Body interactions and regulatory submissions.

Why Join Us?

At Neko Health, you'll work in aninnovative and collaborativeenvironment, shaping the future ofAI/ML-driven and software-enabled medical technologies, while ensuringregulatory compliance and efficient design transfer.

If you’re passionate aboutdesign quality, risk management, and compliance, we’d love to hear from you!

Additional Information

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 Firstcompany; 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.

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