Okay, I've searched for Software Verification Engineer roles in Newton, MA within the medical device industry, requiring 5+ years of experience and skills in Python and Java. I have found 37 positions for you.

Sure. Here's the analysis:

Job Analysis:

The Software Verification Engineer role at Katalyst CRO is fundamentally about ensuring the safety, reliability, and regulatory compliance of medical device software through rigorous verification processes. This role requires someone who not only meticulously designs and implements test plans—covering functional and non-functional requirements such as performance and security—but also executes both manual and automated tests to detect and document defects effectively. Given the regulatory landscape of medical devices, the engineer must have deep knowledge of standards like FDA 21 CFR Part 820, ISO 13485, and IEC 62304, as well as the ability to keep pace with evolving compliance requirements. Critical to success is the capacity to collaborate closely with cross-functional teams (developers, systems engineers) to translate requirements into thorough testing strategies and then communicate results and issues transparently. The candidate will frequently navigate complex problem-solving scenarios, balancing technical accuracy with regulatory rigor, and managing the ambiguity inherent in exploratory testing processes. Success in this role means delivering defect-free, compliant software releases that protect patient safety while enabling efficient product development, typically demonstrated through robust testing documentation, a low defect escape rate, and smooth regulatory audits within the first 6–12 months.

Company Analysis:

Katalyst CRO operates as a globally oriented Contract Research Organization specializing in healthcare and life sciences, with a strong emphasis on regulatory compliance and quality-driven service delivery. Positioned as a trusted partner to pharmaceutical, biotech, and medical device companies, it leverages its expertise across all stages of the product lifecycle, highlighting a mission to accelerate innovation while ensuring adherence to strict quality and regulatory standards. This places the Software Verification Engineer in a pivotal role that must align with the company's client-centric and quality-first values; the environment likely balances rigorous procedural discipline with flexibility to tailor solutions to diverse regulatory challenges. Given the CRO’s advisory and operational model, the role is probably both highly collaborative and client-facing to some extent, requiring clear communication and strategic thinking. The culture may be fast-paced yet structured, rooted in scientific precision and regulatory expertise, demanding that candidates be self-motivated problem-solvers who take ownership of their deliverables. As a contract role in a specialized firm, it serves a strategic need to maintain the highest quality standards for client projects—therefore, the engineer directly impacts Katalyst’s reputation and long-term growth in the medical device regulatory space.

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

• Tell me about a time when you identified a critical software defect during verification that others had missed. How did you handle the situation and communicate it to the team?
• Describe your experience designing comprehensive test plans that comply with FDA or ISO medical device standards. What approach do you take to ensure coverage of all key requirements?
• Can you share an example of collaborating with developers and engineers on a complex software testing effort? How did you manage conflicts or differing perspectives?
• How do you stay current with evolving regulatory requirements such as IEC 62304 and FDA guidance? How have you applied new standards to your testing processes?
• Walk me through your process for developing and executing automated test scripts. What tools and languages have you found most effective for medical device software verification?
• How would you design a test plan to cover both functional and non-functional requirements like security and performance in a medical device software project?
• Imagine you find a software defect late in the testing cycle that could delay the regulatory submission. How would you prioritize and communicate your findings?
• If you were tasked with verifying new software that integrates multiple subsystems with differing specifications, how would you approach testing coordination and risk assessment?
• Why are you interested in working with Katalyst CRO specifically, considering our focus on regulatory excellence and client-centric healthcare solutions?
• How do you see your background and values aligning with Katalyst CRO's mission to accelerate the safe delivery of life-changing therapies?
• Can you describe what motivates you about working in the medical device industry, especially in a contract research environment?
• What do you think are the biggest challenges in software verification for medical devices, and how would you prepare to address them in this role?
• How do you balance the demands of thorough testing with tight project timelines and regulatory deadlines?
• What questions do you have about Katalyst CRO’s approach to software verification or the regulatory challenges our clients face?
• Could you tell me about the typical team structure for software verification here and how this role interacts with leadership and cross-functional stakeholders?