Serve as the primary technical interface for our 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, particularly within the Software Test and documentation realms.
Lead planning for complex software-driven medical devices, perform hazard and harm assessments, and identify 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 using strong familiarity with risk models from ISO 14971.
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 creation of test cases.
Define and oversee system integration over development, and coordinate and plan testing of the system at meaningful milestones to mitigate project risk.

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.
Experience with Machine Learning systems, algorithm management, and real-time/embedded programming.
Familiarity with Agile, version control, and automating compliant CI/CD pipelines.

Principal System Engineer

Key skills