Job Description
In the role you will:
- 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.
The requirements are:
- 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 Software as a Medical Device (SaMD) and AI/ML-based technologies.
Neko Health offers:
- An innovative and collaborative environment.
- The chance to shape the future of AI/ML-driven and software-enabled medical technologies.
- A flexible workplace that focuses on work/life balance.
About Neko Health
Neko Health is a Swedish healthcare technology company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek and has over 500 employees.