Sr. Software Quality Engineer

As a Sr. Software Quality Engineer at Aktiia, you will be responsible for ensuring that our software projects adhere to the regulations and quality standards outlined in IEC 62304. Your role includes taking ownership of software projects for regulatory compliance, managing the process for software releases, and conducting risk analyses to document software risks from design through post-launch. Collaboration with cross-functional teams is essential, as you'll be working closely with Product Management, Operations, and Software Engineering to ensure that all products meet internal procedures and medical device regulations.

To qualify for the Sr. Software Quality Engineer position at Aktiia, candidates should possess a Bachelor’s degree in a technical or scientific field along with a minimum of 5-8 years of experience in a quality assurance or software engineering role within the medical device industry. Familiarity with ISO and FDA Quality System Requirements is crucial. Additionally, candidates should demonstrate strong project management skills and have experience in risk management processes governed by ISO 14971.

In the role of Sr. Software Quality Engineer at Aktiia, you will significantly contribute to product development by overseeing compliance with medical device regulations throughout the software lifecycle. You’ll review software design and development documentation to ensure adherence to quality standards, conduct traceability analyses to confirm project requirements are met, and provide quality inputs to various processes like CAPA investigations. Your leadership will enhance the overall quality assurance efforts within the team.

The work environment for a Sr. Software Quality Engineer at Aktiia is flexible, with options for hybrid work schedules. Your contributions will be integral to the team, requiring you to adapt to changing priorities and independently manage your workload. Occasional international travel (around 10% of the time) is expected to support our global mission of improving cardiovascular health through innovative technology.

A successful Sr. Software Quality Engineer at Aktiia should possess strong project and time management skills to effectively navigate multiple tasks concurrently. Proficiency with tools like MS Teams, Word, Excel, PowerPoint, and eQMS systems is necessary. Furthermore, creative problem-solving abilities are essential for resolving complex issues that arise during software development and validation processes, along with a solid understanding of risk management principles.

When asked about IEC 62304 compliance during your interview for the Sr. Software Quality Engineer position at Aktiia, it’s beneficial to provide specific examples of past projects where you ensured software compliance with this standard. Talk about your role in evaluating documentation, performing risk management activities, and leading quality assurance efforts that met the required regulations.

In your interview, explain your approach to prioritizing tasks by discussing how you assess project deadlines, regulatory importance, and resources available. Mention using project management tools to track progress and communicate effectively with your team to ensure that priorities are clear and tasks stay on schedule.

When discussing methodologies for software quality assurance, emphasize your experience with Agile methodologies and how they contribute to enhancing software quality. Share examples of how implementing Agile practices and continuous feedback loops have led to improvements in product quality and compliance in your previous roles.

In your response, recount a specific instance where you encountered a significant quality issue. Highlight the steps you took to analyze the problem, the solution you implemented, and how it positively impacted the project's outcome. This showcases your problem-solving skills and ability to address challenges in a fast-paced environment.

Demonstrating your familiarity with risk management processes, particularly FMEA, is crucial in your interview. Discuss specific instances where you conducted risk assessments and analyses, detailing how you identified potential risks and implemented mitigation strategies to ensure compliance and product quality.

In your interview, stress the importance of documentation in quality assurance as a key factor for regulatory compliance and project transparency. Illustrate with examples how thorough documentation practices strengthen the software development lifecycle and aid in maintaining consistent quality standards.

Share your experience with various tools for tracking software quality metrics, such as eQMS systems or project management software. Discuss how you utilize these tools to monitor progress, facilitate communication, and identify areas for improvement in software quality throughout its lifecycle.

Employing effective collaboration strategies is vital. Share how you facilitate communication and cooperation among cross-functional teams, perhaps by organizing regular meetings or utilizing collaborative tools, ensuring that everyone remains informed and aligned towards the project's goals.

In addressing cybersecurity considerations, underscore the significance of integrating security measures into quality assurance processes. Provide concrete examples of how you have contributed to reviewing and updating cybersecurity documentation, along with any relevant experiences in ensuring compliance with cybersecurity standards.

Express your genuine interest in Aktiia by highlighting a passion for improving cardiovascular health through cutting-edge technology. Discuss how your background, skills, and values align with the company's mission, and demonstrate your desire to contribute positively to an innovative team dedicated to making a difference.