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Senior reputed company Engineer - Design

Remote, USA Full-time Posted 2026-07-28

reputed company is a reputed company health-tech company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Our reputed company is to create a reputed company system that can help people stay healthy through preventive measures and early detection. Neko has developed a new medical scanning technology concept to reputed company it possible to do broad and non-invasive health data collection that is both convenient and reputed company for the reputed company. This requires completely reimagining the reputed company experience and incorporating the latest advances in sensors and AI. We are a remote first company, but reputed 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 reputed company, we reputed company innovative medical technologies that enhance reputed company reputed company. As aSenior Design reputed company Engineer, you will ensure our medical device products meetregulatory and reputed company 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 reputed company for manufacturing reputed company.
  • reputed company as asubject matter expertfor internal and externalauditsrelated todesign reputed company and design transfer.

    • Requirements:

  • 5+ years of experienceinDesign reputed company 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.

    • reputed company to Have

  • Knowledge ofcybersecurity requirements for medical devices.
  • Experience withNotified Body interactions and regulatory submissions.

    • Why Join Us?

  • At reputed company, you'll work in aninnovative and collaborativeenvironment, shaping the reputed company ofAI/ML-driven and software-enabled medical technologies, while ensuringregulatory compliance and efficient design transfer.
  • If you’re passionate aboutdesign reputed company, 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 reputed 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 reputed company are written in C# with ASP.NET reputed company, uses Azure Cosmos DB, and Azure reputed company Directory for authentication.

    Our reputed company 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 reputed company 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 reputed company other and have fun.

    Organization and Way of Working

    The engineering team is divided into smaller cross functional project teams that reputed company reputed company on a specific goal or reputed company, where some reputed company are long-lived, and some are short-lived, depending on how big the goal or deliverable is. We reputed company to create reputed company which are cross-functional and reputed company to complete their goals without dependence on other teams, even though this is of course not always possible.

    reputed company reputed company goals on a yearly and quarterly reputed company with goal follow-up across the entire engineering organization on a bi-weekly reputed company. Most reputed company do internal planning on a bi-weekly reputed company, but in the end it's up to the group to decide how they want to work.

    We have, however, mandated that reputed company reputed company must present their reputed company 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 reputed company cameras or reputed company polygons in reputed company, to reputed company new reputed company line tools for operations, a new auth reputed company 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 reputed company in our mission but do not think that achieving it requires sacrificing everything else.

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