A thriving and fast-growing innovative and fast-growing medical device company that specializes in developing cutting-edge wearable technologies that improve patient outcomes are looking to expand their quality team and bring in a Software Quality Engineer on a full-time basis!
This organization have created a user-friendly wearable medical devices that empowers patients and healthcare professionals alike by tracking real-time digital data around the clock.
They need someone who is able to be fully responsible for ensuring the quality and compliance of the software systems, which are integral to the functionality and safety of the wearable medical devices, more details of the role are listed below:
- Validate software performance, functionality, and security in alignment with regulatory requirements.
- Ensure software development processes comply with industry standards (e.g., IEC 62304, ISO 13485) and FDA regulations.
- Identify, document, and track software defects, ensuring they are addressed promptly
- Ensure that potential risks associated with software are identified, documented, and managed throughout the entire software lifecycle.
- Conduct additional risk assessments and participate in the development of risk mitigation strategies related to software.
Ideally this individual would possess a Bachelor’s degree in Computer Science, Software Engineering, or a related field.
Furthermore, 3-5 years of experience in software quality assurance is required, preferably within the medical device or healthcare industry.
Any experience working with programming languages (e.g., Python, C++) and software testing tools (e.g., Selenium, JIRA) is a bonus.
If this is a position which you feel could potentially be a good fit get your resume sent over to me at a.willoughby@x4lifesciences.com and I will let you know any feedback.