Senior Quality Engineer - Design

Job not on LinkedIn

May 22

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Logo of Neko Health

Neko Health

Healthcare Insurance • Wellness

Neko Health is a healthcare company offering advanced body scans and health check services in the United Kingdom and Sweden. They focus on providing comprehensive health evaluations using cutting-edge technology, allowing clients to receive instant results and detailed consultations with doctors. Their services include monitoring body measurements, blood vessels, heart rhythm, diabetes factors, and skin mapping. Neko Health emphasizes preventive healthcare and annual check-ups to help clients track changes and improve their health over time. The company aims to revolutionize healthcare by making thorough health checks accessible and emphasizing prevention over treatment.

11 - 50 employees

Founded 2018

⚕️ Healthcare Insurance

🧘 Wellness

💰 Series A on 2023-07

📋 Description

•Neko Health is a Swedish health-tech company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. •Our vision is to create a healthcare system that can help people stay healthy through preventive measures and early detection. •Neko has developed a new medical scanning technology concept to make it possible to do broad and non-invasive health data collection that is both convenient and affordable for the public. •This requires completely reimagining the healthcare experience and incorporating the latest advances in sensors and AI. •We are a remote first company, but the company is based in Stockholm and has over 200 employees across Europe. •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.

🎯 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. •Nice to Have: Experience with Notified Body interactions and regulatory submissions.

🏖️ Benefits

•Innovative and collaborative environment•Shaping the future of AI/ML-driven and software-enabled medical technologies•Ensuring regulatory compliance and efficient design transfer

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