Principal System Engineer:
At Full Spectrum, our Systems Engineering team is the core differentiator that sets us apart from standard medical device service companies. As a Principal System Engineer,you aren't just using a highly efficient and compliant process, you will be working with Full Spectrum clients to improve their process and provide life-saving technology in a more repeatable manor. You will lead diverse projects, translating complex clinical needs into robust, secure, and compliant engineering realities.
The 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.
Requirements Mastery: Develop and implement requirement schemas and hierarchies using industry-standard RM tools, ensuring flawless allocation and traceability.
V&V Strategy & Regulatory Mastery:
You will define the path to market by establishing rigorous V&V strategies within an iterative development environment.
V&V Leadership: Oversee system and software V&V approaches, including test planning, design, and the creation of comprehensive test cases.
Testing Strategy: Implement lifecycle-based testing (IEC 62304), covering everything from unit testing to system-level GUI testing.
System Verification: 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.
Standard Compliance: 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.
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.
The base salary for this position is $150,000 to $205,000 annually, and the role is bonus eligible.
The final salary offer is determined by factors such as experience, location, skills, education, and market conditions. **
