Senior Quality Engineer - Design

About the Role

Join Neko Health, a pioneering health-tech company, as a Senior Design Quality Engineer to ensure our innovative, AI-enabled medical scanning technologies meet the highest global regulatory and quality standards throughout the product lifecycle.

Responsibilities

• Improve and implement design control processes across the product lifecycle for medical devices.
• Lead Risk Management activities, focusing on systematic identification and mitigation of risks associated with software-driven and AI-enabled technologies, adhering to ISO 14971.
• Oversee verification and validation strategies for both hardware and software components.
• Ensure all design changes are properly assessed, documented, and compliant with regulatory requirements.
• Support the creation and maintenance of technical documentation for regulatory submissions (e.g., DHF, Technical Documentation).
• Facilitate design reviews, ensuring adherence to safety and usability requirements.
• Drive the design transfer process, collaborating with Manufacturing and Operations for a smooth production handover and ensuring process validation/production controls are established.
• Act as a subject matter expert during internal and external audits related to design quality and design transfer.

Requirements

• 5+ years of experience in Design Quality Engineering specifically within the medical device industry.
• Deep expertise in quality standards including ISO 13485, IEC 62304, IEC 62366, and risk management (ISO 14971).
• Proven experience managing change control and executing design transfer to manufacturing.
• Strong understanding of the development lifecycle for both hardware and software in medical devices.
• Direct experience working with Software as a Medical Device (SaMD) and AI/ML-based technologies is essential.
• Excellent written and verbal communication skills in English, coupled with strong cross-functional collaboration abilities.

Nice-to-Haves

• Knowledge of cybersecurity requirements pertinent to medical devices.
• Prior experience interacting with Notified Bodies and supporting regulatory submissions.

Role Impact

At Neko Health, you will be instrumental in shaping the future of preventive healthcare by ensuring that our cutting-edge technologies are not only innovative but also fully compliant, safe, and ready for mass production.