Principal System Engineer

Opportunity

Strategic Leadership & Client Impact: In this high-visibility role, you serve as the primary technical interface for our clients, driving Software Systems Engineering for mission-critical medical device projects.

Lead & Delegate: 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.

Process Innovation: Consult with Test Process owners to refine methodologies while minimizing audit exposure.

Technical Architecture & Risk Management: You will be responsible for how teams address "Safety and Security by Design" of complex systems, ensuring protective measures are embedded from the earliest stages of development.

Safety Risk Analysis: Lead planning for complex software-driven medical devices, perform top-down hazard and harm assessment working with Full Spectrum clients’ clinical tam or medical director, performing bottom-up failure analysis (FMEA) and identifying potential risk to safety.

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.

Qualifications

• Education: Bachelor’s degree in Software, Electrical, Biomedical, or Computer Engineering (or a related science discipline).
• Experience: Minimum of 8 years of relevant experience in Systems Engineering.
• Leadership: Proven track record in medical device development, identifying project risks, and communicating clearly with stakeholders.
• Technical Knowledge: Deep understanding of design controls, software lifecycle coaching, and automated Scrum processes for continuous integration.

Desirable Skills: (Nice to Have): Technical Proficiencies: Scripting in Python or C/C++, code inspection, and Object-Oriented Programming.

Emerging Tech: Experience with Machine Learning systems, algorithm management, and real-time/embedded programming.

Modern Methodology: Familiarity with Agile, version control, and automating compliant CI/CD pipelines.

Pay

The base salary for this position is $150,000 to $205,000 annually, and the role is bonus eligible.