Senior Design Quality Engineer - Remote

Overview

Neko Health is a Swedish health-tech company focused on preventive healthcare through innovative medical scanning technology. As a remote-first company, we prioritize creating a healthcare system that is accessible and efficient.

In Short

• Ensure medical device products meet regulatory and quality standards.
• Drive design controls, risk management, and verification & validation.
• Collaborate with Manufacturing and Operations for design transfer.
• Support technical documentation for regulatory submissions.
• Oversee design changes and ensure compliance.
• Act as a subject matter expert for audits related to design quality.
• Implement design control processes across product lifecycle.
• Facilitate design reviews for safety and usability compliance.
• Ensure process validation and production controls are in place.
• Lead risk management for software-driven and AI-enabled technologies.

Requirements

• 5+ years of experience in Design Quality Engineering in the medical device industry.
• Expertise in ISO 13485, IEC 62304, IEC 62366, and ISO 14971.
• Experience with change management and design transfer.
• Strong understanding of hardware and software development for medical devices.
• Experience with Software as a Medical Device and AI/ML technologies.
• Skilled in cross-functional collaboration and problem-solving.
• Excellent communication skills in English.
• Knowledge of cybersecurity requirements for medical devices is a plus.
• Experience with regulatory submissions and Notified Body interactions is a plus.

Benefits

• Innovative and collaborative work environment.
• Opportunity to shape the future of AI/ML-driven medical technologies.
• Focus on regulatory compliance and efficient design transfer.
• Passion for design quality and risk management is valued.