Senior Quality Engineer – Design

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.

Nice to Have

• Knowledge of cybersecurity requirements for medical devices.
• Experience with Notified Body interactions and regulatory submissions.

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!