Principal System Engineer
Location
United States
Posted
104 days ago
Salary
$150K - $205K / year
Seniority
Lead
Job Description
Principal System Engineer
Full Spectrum
• Serve as the primary technical interface for clients, driving Software Systems Engineering for mission-critical medical device projects. • Manage project execution by aligning client needs with team tasks and deliverables. • Collaborate with Regulatory Affairs partners to define system intent, launch strategies, and regulatory pathways. • Provide real-time guidance, training, and problem-solving for engineers in Software Test and documentation realms. • Lead planning for complex software-driven medical devices and perform risk assessments in collaboration with clinical teams. • Drive the process for threat model analysis, cyber risk assessments, and incident reporting to ensure FDA compliance. • Develop and implement requirement schemas and hierarchies ensuring allocation and traceability.
Job Requirements
- Bachelor’s degree in Software, Electrical, Biomedical, or Computer Engineering (or a related science discipline).
- Minimum of 8 years of relevant experience in Systems Engineering.
- Proven track record in medical device development, identifying project risks, and communicating clearly with stakeholders.
- Deep understanding of design controls, software lifecycle coaching, and automated Scrum processes for continuous integration.
- 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.
Benefits
- bonus eligible
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