Quality assurance engineer - Medical device startup
Today, more people die from suicide than from war, crime and terrorism combined.
Our mission is to develop new ways to combat mental health issues with science and technology.
Our first product, Flow, is a medication-free treatment for depression, the leading cause of disability in the world. It combines a brain stimulation wearable and an app-based therapy program to create a new effective, safe, and affordable way to treat depression, at home.
We are now looking for a Quality assurance engineer to join our team in Malmö.
This position is for you, if you:
- have a natural feeling for quality, are organized, and have an intuitive understanding of technology.
- want to bring a new treatment to the world to a disease that affects 300M people worldwide.
- want to work in the intersection of medical technology, digital health, hardware, psychology and artificial intelligence.
- have a strong passion and integrity for what you do and want to challenge the way we treat mental health problems today.
- be an early employee in a startup with truly global potential and ambitions, and be a part of shaping the culture and future of the company.
The purpose of this position is to ensure that we are compliant with relevant regulations as we expand globally (right now Flow is CE marked as a medical device in Europe).
Your main responsibilities will be:
- Assist our supply and quality managers with quality controls and documentation.
- Maintain and improve our existing quality management system and processes.
- Design control, testing, verification and validation of updated and newly designed products and services, both hardware and software.
- Work with our suppliers to improve our quality control and manufacturing processes.
- Assist customer support with technical troubleshooting.
If you have a good profile and are passionate about how to tackle mental health issues with tech we can offer you:
- Extremely committed co-workers
- A chance to work with a truly unique product with the potential to change millions of lives for the better
- Competitive compensation that will grow with the success of the company
Skills and experiences we are looking for
We would love to hear from you if you have a BSc in a related engineering field. Experience in working with medical devices, product and/or software quality assurance is desired but not strictly required. You are fluent in English.
Knowledge of all or any of these standards/regulations is a merit: ISO 13485:2016, ISO 9001, FDA QSR, IEC 62304, ISO 14971, IEC 60601.
We are ambitious, focused on doing rather than talking, are analytical, and passionate about the problem we are trying to solve. If you think these are traits you also possess we would be honored to hear from you.
Desired personal qualities:
- Intellectual breadth
- Ability to admit when wrong
- Ability to work in a diverse team
- Sense of humor
- Emotional openness
The position is based in Malmö, Sweden.
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