What are the responsibilities and job description for the Sr. Principal Software Quality Engineer position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Partner with development teams to ensure compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and cybersecurity standards.
- Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls.
- Lead software risk management (RMF), including risk evaluation, control, and mitigation.
- Drive Secure Product Development Framework (SPDF) and software security best practices.
- Support Agile software development teams, ensuring regulatory and quality compliance.
- Own and resolve CAPAs related to design control and software quality processes.
- 8 years in medical device software quality engineering.
- Deep knowledge of 21 CFR 820, ISO 13485, IEC 62304, IEC 82304, AAMI TIR45, ISO 14971, IEC 60601, and cybersecurity standards.
- Strong experience in SaMD, SiMD, cloud-based software, AI/ML, and security risk management.
- Hands-on experience with design control documentation, risk management, and DHF oversight.
- Proficiency in Microsoft Office, Azure DevOps, statistical tools (e.g., Minitab), and vulnerability scanning.
- Preferred: ASQ CQE, Six Sigma Black Belt/Green Belt, ISO/IEC 27001, cloud infrastructure expertise.
