Senior Design QA Engineer

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.


Nice to Have
• 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!