Principal System Engineer (Remote)

Full Spectrum partners with leading companies in MedTech to develop cutting-edge software for medical devices. As a Principal System Engineer, you will lead diverse projects, translating complex clinical needs into robust engineering realities and serving as the primary technical interface for clients on mission-critical medical device projects.

Responsibilities:

• 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, particularly within the Software Test and documentation realms
• Consult with Test Process owners to refine methodologies while minimizing audit exposure
• Ensure protective measures are embedded from the earliest stages of development
• Lead planning for complex software-driven medical devices, perform top-down hazard and harm assessment working with Full Spectrum clients’ clinical team or medical director, performing bottom-up failure analysis (FMEA) and identifying potential risk to safety
• Drive the process for threat model analysis, cyber risk assessments, vulnerability analysis, and incident reporting to ensure full FDA compliance
• Apply practical risk management throughout the entire product lifecycle, utilizing strong familiarity with both design and process risk models from ISO 14971
• Develop and implement requirement schemas and hierarchies using industry-standard RM tools, ensuring flawless allocation and traceability
• Define the path to market by establishing rigorous V&V strategies within an iterative development environment
• 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
• Define and oversee system integration over development, define performance characterization tests and test requirements and test methods, coordinate and plan testing of the system at meaningful milestones to mitigate project risk and to meet defined performance requirements
• 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; Hardware & Safety: IEC 60601-1, IEC 60601-1-8; Quality & Process: 21 CFR Part 820, IEC 13485, and ISPE GAMP-5; Usability: IEC 62366 and basic usability design principles

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
• Master's or PhD in an Engineering or Science discipline
• 4+ years of hands-on experience in software development
• Scripting in Python or C/C++, code inspection, and Object-Oriented Programming
• Experience with Machine Learning systems, algorithm management, and real-time/embedded programming
• Familiarity with Agile, version control, and automating compliant CI/CD pipelines