Senior Software Quality Engineer

The key responsibilities of a Senior Software Quality Engineer at Hilo by Aktiia include ensuring compliance with software regulations like IEC 62304, leading software projects towards regulatory compliance, performing risk analysis, and conducting thorough reviews of software lifecycle documentation. The engineer also collaborates with various branches such as Product Management and Regulatory to guarantee that all processes meet the required quality standards.

To qualify for the Senior Software Quality Engineer position at Hilo by Aktiia, candidates should possess a Bachelor's degree in a technical or scientific field alongside 5-8 years of experience in quality or software engineering within the medical device industry. Candidates should also have knowledge of ISO and FDA standards, strong leadership abilities, and proficiency in project management skills.

The Senior Software Quality Engineer at Hilo by Aktiia plays a crucial role in product development by ensuring that all software meets rigorous quality and regulatory requirements from the very beginning through to product launch. This role involves continuous oversight of compliance with quality practices, leading risk management initiatives, and validating software lifecycle documentation to support successful product deliverables.

Experience in the medical device industry is essential for a Senior Software Quality Engineer at Hilo by Aktiia, especially involving software development, quality assurance, and regulatory compliance. Familiarity with standards such as IEC 62304, ISO 13485, and Cybersecurity requirements will further enhance a candidate's fit for the role, as it pertains to ensuring product quality and safety in healthcare.

The work environment for a Senior Software Quality Engineer at Hilo by Aktiia is dynamic and collaborative, embodying a startup culture where innovation and adaptability are key. Engineers have the flexibility of a hybrid work schedule, allowing them to balance personal and professional commitments while being part of a transformative team committed to improving cardiovascular health.

In answering this question, focus on specific projects where you applied IEC 62304 standards, detailing how you ensured regulatory compliance throughout the software lifecycle. Highlight your understanding of the standard's requirements and how they influence software development processes in the medical device industry.

Articulate your approach to risk management, emphasizing techniques such as risk analysis, risk evaluation, and mitigation strategies you have implemented in past projects. Discuss your familiarity with ISO 14971 and how you've leveraged it to assess and manage software-related risks.

Highlight your experience working with teams across various functions by discussing strategies such as regular meetings, status reports, and collaborative tools. Emphasize your ability to adapt communication styles to suit different audiences while ensuring that quality standards are clearly conveyed.

Use the STAR method (Situation, Task, Action, Result) to describe the context of the quality issue, what was at stake, the specific steps you took to address it, and the positive outcome that resulted from your resolution efforts.

Discuss your strategies for prioritization such as the use of matrices or productivity tools, considering deadlines, regulatory requirements, and project impact. Showing your ability to assess and adjust priorities based on project phases or stakeholder needs reflects your adaptability and organizational skills.

Demonstrate your knowledge about Hilo by Aktiia’s innovative continuous blood pressure monitor, discussing how it leverages advanced technology to monitor cardiovascular health more effectively. Relate this to its impact on patient care, emphasizing the importance of quality software in delivering a reliable product.

Articulate the critical role of documentation in ensuring compliance and traceability, especially in the medical device industry. Highlight how good documentation practices support quality assurance processes, facilitate audits, and provide a clear record for future reference.

Discuss your experience participating in Agile project methodologies, mentioning tools you've used like Scrum or Kanban. Highlight how Agile practices support flexibility, continuous improvement, and collaboration within software quality assurance teams.

Detail the resources you use to keep abreast of regulatory changes, such as industry publications, webinars, and professional networks. Discuss any memberships in relevant organizations that help you stay informed about evolving standards and regulations.

Outline your systematic approach to evaluating software anomalies, discussing techniques such as root cause analysis and collaboration with development teams to propose corrective measures. Emphasize the importance of documenting findings to track recurrent issues and prevent future occurrences.