Senior Design QA 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 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 (hardware and firmware) meet regulatory and quality standards throughout their development lifecycle. Reporting to the Instrument Design QA Manager, you will execute design controls, risk management, verification & validation, and design transfer activities, ensuring compliance with ISO 13485, IEC 60601-1, IEC 62471, EU MDR, and FDA regulations. You'll bring a systems engineering mindset to quality assurance, connecting the dots across hardware, firmware, and systems integration. Working within our modern electronic Quality Management System (eQMS), you'll drive efficiency through digital tools, automation, and process innovation. Your work will directly contribute to the company's success by ensuring our medical devices are not only compliant but also optimized for safety and performance. We're looking for a pragmatic, self-leading individual with an open mindset who thrives in a modern, collaborative environment where quality engineering and development work hand-in-hand. Responsibilities:

Lead risk management activities (ISO 14971) for medical devices, identifying, evaluating, and controlling risks with a pragmatic, engineering-driven approach.

Execute design control processes across the product lifecycle, including verification & validation strategies, design reviews, change assessments, and design transfer to manufacturing.

Build and maintain audit-ready technical documentation in our eQMS, including DHFs, risk files, and regulatory submissions—leveraging digital tools and automation rather than paper-based processes.

Drive process improvements in collaboration with stakeholders, implementing modern QA tooling, AI-driven documentation, and automated testing frameworks to enhance efficiency.

Coordinate cross-functional quality activities with engineering, manufacturing, and regulatory teams, using strong project management skills to ensure timely delivery.

Act as a subject matter expert for internal and external audits related to medical device design quality, design controls, and design transfer.

Requirements:

5+ years of experience in medical device industry, with focus on hardware, firmware, or electrical equipment.

BSc or MSc in engineering, systems engineering, physics, biomedical engineering, or equivalent technical discipline.

Deep expertise in design control and risk management for medical devices, with hands-on experience meeting EU MDR (2017/745), ISO 13485 and US FDA (21 CFR Part 820, Part 11) requirements.

Strong knowledge of medical device standards including ISO 14971, IEC 60601-1, IEC 62471, IEC 62304, IEC 62366, and ISO 10993.

Solid understanding of hardware and firmware development processes, with hands-on experience in design controls, verification & validation, and design transfer.

System Engineering mindset—you connect the dots, see the whole picture, and understand how hardware, firmware, and systems integrate.

Pragmatic and solution-oriented with ability to balance compliance rigor with development velocity and business needs.

Self-leading and proactive—you take ownership, drive initiatives independently, and know when to escalate or collaborate.

Open mindset—comfortable with modern, digital-first ways of working (eQMS, automation, AI-driven tools).

Strong project management skills with ability to coordinate cross-functional activities and deliver on time.

Excellent collaboration and communication skills—you work effectively across engineering, manufacturing, regulatory, and operations.

Commitment to product safety and quality with strong attention to detail and analytical problem-solving skills.

Excellent written and verbal communication skills in English.

Knowledge of firmware development and embedded systems.

Experience with Notified Body interactions and regulatory submissions.

Background in high-growth technology companies or startups.

Active participation in medical device industry organizations and standards committees.

Swedish language skills.

Why Join Us?

At Neko Health, you'll work in a modern, collaborative environment where quality engineering is integrated with product development.

You'll leverage cutting-edge digital tools, automation, and an eQMS to drive both compliance and innovation. This isn't a traditional paper-pushing QA role; it's an opportunity to shape quality processes, work hand-in-hand with talented engineering teams, and make a real impact on healthcare outcomes.

If you're a pragmatic, self-leading quality engineer who brings a systems engineering mindset, thrives on solving complex problems, and wants to work at the intersection of quality and innovation, we'd love to hear from you!