Okay, I've searched for Software Quality Engineer roles in Irvine, CA within the medical device industry, requiring 3+ years of experience, a Bachelor’s degree in Computer Science or related disciplines, and full-time positions. I have found 47 positions for you.

Sure. Here's the analysis:

Job Analysis:

The Software Quality Engineer role at Masimo is fundamentally about guaranteeing the quality, safety, and regulatory compliance of software embedded in medical devices—a responsibility that directly impacts patient outcomes and company reputation. Beyond routine QA tasks, this role entails deep involvement in the entire software development life cycle, from reviewing design requirements to validating test reports and managing risk. Given the stringent regulatory environment, the candidate must navigate complex standards such as FDA CFR 21 820 and ISO 13485, blending technical rigor with regulatory savvy. Success in this role means not only identifying and resolving software defects but proactively managing risks and integrating cybersecurity concerns to protect patient data and device performance. The role demands collaboration across functions—development, regulatory, and product teams—requiring excellent communication to embed quality as a competitive advantage. The candidate will face challenges like balancing robust testing with agile development timelines, interpreting and applying evolving regulations, and maintaining meticulous documentation like Design History Files. Ultimately, success will manifest in reliable software that meets compliance, mitigates risks, and strengthens Masimo’s market leadership in medical device innovation.

Company Analysis:

Masimo is a global leader in innovative noninvasive patient monitoring technology with a strong history of solving complex medical challenges. Its market position as an innovator and 'world changer' sets a high bar for quality, safety, and cutting-edge performance, which deeply informs the expectations for this Quality Engineer role. The company culture, described as fueled by 'what-ifers' and 'never-say-never-ers,' suggests a dynamic, mission-driven environment valuing creativity alongside discipline. For a quality engineering hire, this means thriving requires adaptability, proactive problem-solving, and a passion for precision in a fast-evolving technology field that touches lives. Organizationally, this role sits at the intersection of software development, regulatory affairs, and product assurance—likely an individual contributor with strong cross-functional influence and exposure to leadership through critical quality initiatives. Strategically, the company is investing in quality to maintain and advance its competitive edge, especially given the sensitive nature of medical devices and the increasing importance of cybersecurity. Consequently, this hire supports both the stability and growth of Masimo’s product portfolio by ensuring software integrity and compliance in a highly regulated industry.

Absolutely. Here are some mock interview questions that could come up:

• Behavioral: Tell me about a time when you identified a significant defect during software testing in a regulated environment. How did you address it?
• Behavioral: Describe an experience where you had to collaborate with multiple teams to integrate risk controls into software development. What challenges did you face and how did you overcome them?
• Behavioral: Can you share an example of how you maintained attention to detail while managing competing priorities?
• Behavioral: Give an example of a situation where you had to communicate complex technical or regulatory information to non-technical stakeholders. How did you ensure understanding?
• Technical: How do you approach developing and implementing a software quality assurance process for medical device software?
• Technical: Explain your experience working with FDA CFR 21 820 and ISO 13485 regulations. How do these shape your testing and validation strategies?
• Technical: What methodologies do you use to perform risk analysis for software in medical devices, and how do you prioritize identified risks?
• Technical: Describe your approach to validating software cybersecurity in medical devices. What factors do you consider critical?
• Situational: Imagine post-market surveillance has revealed a software-related issue with one of Masimo’s devices. How would you lead the investigation and resolution process?
• Situational: You discover a gap in documentation that could affect regulatory compliance during a design history file review. What steps would you take?
• Situational: If development demands a change in feature implementation that may introduce new risks, how would you assess and communicate the implications?
• Company Fit: What attracts you to Masimo's mission of improving lives through innovative patient monitoring technology?
• Company Fit: How do you see your personal values aligning with Masimo’s culture of 'what-ifers' and 'never-say-never-ers'?
• Company Fit: Given Masimo’s focus on noninvasive monitoring, how do you think software quality engineering contributes to its competitive advantage?
• Questions for Interviewer: How does Masimo’s quality engineering team collaborate with product development and regulatory teams during the software lifecycle?
• Questions for Interviewer: What are the current biggest challenges Masimo faces in maintaining software quality and regulatory compliance?
• Questions for Interviewer: Can you describe the growth opportunities and career path for someone in the Software Quality Engineer role here?