Seer is a 4 year-old fast growing scale-up employing over 160 staff with an ambitious Research and Development and commercialisation agenda.
Seer is developing technology to revolutionise the diagnosis and management of neurological conditions, with a special focus on epilepsy. Our mission is to deliver deep personalised clinical insights and advance patient experience with leading-edge technology.
Our technology consists of wearable devices, a cloud platform, mobile apps and machine learning systems. These systems are at the core of our at-home video-EEG-ECG monitoring and diagnostic service - the first of its kind. Seer has already made a big impact across Australia over the last four years and is now building for international expansion.
Since launching in 2017 Seer’s at-home epilepsy diagnosis service has seen over 6,000 Australians who would have required more than 30,000 days in Australian hospitals at a cost to states and territories of more than $50m. That is 85 bed years diverted from the hospital system within 4 years of operation. And patient waiting times have dropped from several months to a few weeks.
Seer is now poised to expand its reach into other conditions that can be monitored and managed at home rather than in hospital - including cardiac and sleep.
About the Role
We are looking for a Software Quality Officer to join our regulatory and compliance team and help us achieve the regulatory goals we have set for our cloud-based medical data platform. While we value experience and expertise in software development and in medical devices, we are particularly interested in someone who will work effectively with others in their team and across the wider software group and who can grow to own the medical device regulatory concerns of our software.
- To work with our Software Engineering team to ensure sufficient automated and manual testing is performed and that evidence of this is documented
- Contributing to the development and review of standard operating procedures related to software development and maintenance
- To own and maintain registers of software dependencies (SOUP)
- To work with product managers and tech leads to understand and provide feedback into new requirements
- To align the Software Engineering practice to FDA/ISO 13485 processes
- To document software changes and ensure internal processes are being followed within the teams
- Documenting and reviewing acceptance criteria for new software changes
- Maintain documentation and software risk register in a controlled documentation system
- Work with the team to oversee and maintain the software development and validation procedure(s) associated with a product’s life cycle
- Documenting defects for resolution
- To champion quality across the software group and deliver training of relevant software procedures
- Perform post-market surveillance and vigilance reporting
- Understanding of quality assurance for software development
- Understanding of manual testing of web applications
- Understanding of automated testing frameworks
- Understanding of cloud technologies (ideally AWS)
- Desired: experience with JIRA/Greenlight Guru/Wrike
- Desired: cross-functional testing experience (load, penetration, UAT)
- Desired: experience with medical technology standards (ISO 13485, IEC 62304/82304, IEC62366)
- Desired: experience with product documentation requirements for the FDA 510(k) submission process
- Willingness to learn more about medical technology standards if not familiar
- Desired: mobile app testing experience
- Desired: information security testing experience
- Experience working in an Agile development environment
What we offer
- An opportunity to work with the best of the best, solving life-changing problems
- Professional development and career growth
- Working in an inclusive environment that promotes diversity
- Competitive salary