The Senior Design Quality Engineer will lead quality assurance for medical devices, ensuring compliance with regulatory standards and managing design controls, risk assessment, and documentation throughout product development.
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 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 14971).
- 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.
- Knowledge of cybersecurity requirements for medical devices.
- Experience with Notified Body interactions and regulatory submissions.
Nice to Have
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.
Top Skills
Asp.Net Core
Azure Active Directory
Azure Cosmos Db
C#
C++
Iec 62304
Iec 62366
Iso 13485
Iso 14971
Python
React
Typescript
Similar Jobs
Software
Lead the EMEA/APAC Technical Support team, ensuring customer issues are resolved effectively while improving service processes and team performance.
Top Skills:
APIsPostman
Artificial Intelligence • Machine Learning • Natural Language Processing • Conversational AI
As a Senior Backend Developer, you'll enhance Smartcat's platform API, focus on scalable architecture, and improve integration libraries.
Top Skills:
.Net Core (C#)Amazon AwsElasticsearchElk (Efk)GrafanaKafkaMongoDBPostgresPrometheusPython
Cloud • Security • Software • Cybersecurity • Automation
As a Multinational Tax Manager, you will ensure compliance with global tax obligations, manage audits, and enhance tax processes, collaborating with various teams.
Top Skills:
AvalaraCoupaExcelGoogle SuiteNetSuiteSalesforceZuora
What you need to know about the Charlotte Tech Scene
Ranked among the hottest tech cities in 2024 by CompTIA, Charlotte is quickly cementing its place as a major U.S. tech hub. Home to more than 90,000 tech workers, the city’s ecosystem is primed for continued growth, fueled by billions in annual funding from heavyweights like Microsoft and RevTech Labs, which has created thousands of fintech jobs and made the city a go-to for tech pros looking for their next big opportunity.
Key Facts About Charlotte Tech
- Number of Tech Workers: 90,859; 6.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Lowe’s, Bank of America, TIAA, Microsoft, Honeywell
- Key Industries: Fintech, artificial intelligence, cybersecurity, cloud computing, e-commerce
- Funding Landscape: $3.1 billion in venture capital funding in 2024 (CED)
- Notable Investors: Microsoft, Google, Falfurrias Management Partners, RevTech Labs Foundation
- Research Centers and Universities: University of North Carolina at Charlotte, Northeastern University, North Carolina Research Campus
