Senior Software Quality Engineer, Reliability/Compliance

What you'll do

• Support software quality and reliability for Cardiac Ablation Solutions while ensuring compliance with FDA, MDR, and ISO standards.
• Review and approve Design History File documents including requirements, test protocols, verification, and validation reports.
• Develop and review documentation for traceability, testability, and compliance according to standard operating procedures.
• Participate in software risk analysis, defect assessments, and the tracking of software quality metrics.
• Provide quality support for post-market activities, including issue assessments, health risk assessments, and CAPAs.
• Recommend design or test methods to improve product reliability, security, and overall software processes.
• Collaborate with R&D, regulatory, and clinical teams to ensure alignment on quality and compliance requirements.
• Read and interpret existing software code to collaborate with engineers on necessary development tasks.

What we're looking for

• Bachelor's degree with 4 years of relevant experience, Master's with 2 years, or PhD with 0 years of relevant experience.
• Unrestricted U.S. work authorization.
• Experience ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485.
• Experience creating risk analysis documentation such as FMEAs and FTAs (preferred).
• Ability to perform simple coding tasks and interpret existing software code (preferred).
• 2+ years of experience in a medical device or other regulated industry like defense or aerospace (preferred).
• Experience using or working with products built on Python, Qt, Docker, and Linux (preferred).
• Certification in quality systems or regulatory affairs such as Six Sigma or ASQ (preferred).