Principal Systems Engineer (Irvine)

About the Job

We are seeking a highly skilled Principal Systems Engineer to join our fast-paced, mission-driven medical device team. The ideal candidate will have a strong foundation in electrical, biomedical or systems engineering with demonstrated experience in multidisciplinary medical device system development. This role is critical to ensuring seamless integration across complex product architectures, guiding teams through the full product lifecyclefrom concept through FDA submission and commercialization.

The Principal Systems Engineer will lead systems-level design and integration activities, translating clinical and user needs into engineering requirements and ensuring that design outputs meet performance and regulatory expectations. This individual will thrive in a matrixed environment, working cross-functionally with electrical, mechanical, software, and clinical teams to deliver safe, reliable, and innovative medical technologies.

Key Responsibilities

• Lead systems engineering activities from concept through verification, validation, and regulatory submission.
• Translate clinical and user needs into clear, testable system and subsystem requirements.
• Develop and maintain system architecture, block diagrams, and interface control documents.
• Oversee risk management, FMEA, and system-level hazard analysis in accordance with ISO 14971.
• Drive design reviews, integration testing, and system verification / validation activities.
• Collaborate closely with electrical, mechanical, and software engineering teams to ensure cohesive system performance and design integrity.
• Serve as the primary technical liaison across functions, facilitating decision-making and resolving cross-disciplinary challenges.
• Contribute to regulatory documentation and support FDA submissions, preferably for invasive medical devices.
• Mentor junior engineers and foster a collaborative, high-performing technical culture.
• Ensure compliance with design control processes, quality standards, and applicable regulatory requirements (e.g., IEC 60601, ISO 13485).

Qualifications

• Bachelors or Masters degree in Electrical Engineering, Biomedical Engineering or Systems Engineering, or related technical discipline.
• 15+ years of experience in systems engineering within the medical device or similarly regulated industry.
• Proven experience leading cross-functional teams through the development of complex electromechanical systems.
• Prior experience with FDA submission and design control documentation; invasive device experience strongly preferred.
• Hands-on understanding of electrical systems, embedded software, and mechanical integration principles.
• Strong analytical, problem-solving, and communication skills.
• Demonstrated ability to thrive in a matrixed organization, coordinating efforts across engineering, quality, clinical, and regulatory functions.
• Familiarity with relevant regulatory standards.
• Excellent organization and documentation skills, with a detail-oriented and execution-focused mindset.

Preferred Qualifications

• Advanced degree (M.S. or Ph.D.) in a related field.
• Experience with model-based systems engineering (MBSE) tools and methods.
• Experience in startups or fast-paced product development environments.
• Experience with medical systems.