Principal System Engineer

Strategic Leadership & Client Impact:

• Manage project execution by aligning client needs with team tasks and deliverables.
• Consult & Partner: Collaborate with Regulatory Affairs partners to define system intent, launch strategies, and regulatory pathways.
• Mentor & Coach: Provide real-time guidance, training, and problem-solving for engineers, particularly within the Software Test and documentation realms.

Technical Architecture & Risk Management:

• Safety Risk Analysis: Lead planning for complex software-driven medical devices, perform top-down hazard and harm assessment.
• Cybersecurity Strategy: Drive the process for threat model analysis, cyber risk assessments, vulnerability analysis, and incident reporting to ensure full FDA compliance.
• Lifecycle Risk: Apply practical risk management throughout the entire product lifecycle, utilizing strong familiarity with both design and process risk models from ISO 14971.

V&V Strategy & Regulatory Mastery:

• Oversee system and software V&V approaches, including test planning, design, and the creation of comprehensive test cases.
• Implement lifecycle-based testing (IEC 62304), covering everything from unit testing to system-level GUI testing.
• Act as a subject matter expert on key standards and FDA guidance, including: Software & Risk: IEC 62304, ISO 14971, TIR-32, TIR-45, TIR 80001, and IEC 81001-5-1.