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Neko Health · 1 month ago

Senior Quality Engineer - Design

United States

Full-time

Remote

Senior Level

5+ years exp

Neko Health is a Swedish healthcare technology company focused on preventative health and early detection. As a Senior Design Quality Engineer, you will ensure compliance with regulatory and quality standards throughout the development of medical device products, driving design controls, risk management, and verification & validation processes.

Artificial Intelligence (AI)Health CareHospital

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

Qualification

Design Quality EngineeringISO 13485Risk ManagementVerification & ValidationChange ManagementSoftware as a Medical DeviceAI/ML TechnologiesCybersecurity KnowledgeRegulatory SubmissionsCross-functional CollaborationProblem-solvingCommunication Skills