Lead Systems Engineer - Medical Devices

Note : this position is only on-site in Irvine, CA

About the Role

Join our innovative and mission-driven medical device team as a Principal Systems Engineer. We are on the lookout for a highly qualified engineer with a solid background in electrical, biomedical, or systems engineering, along with proven experience in multidisciplinary medical device development. This position is vital for ensuring seamless integration across intricate product architectures, guiding teams from concept through to FDA submission and commercialization.

As a Lead Systems Engineer, you will spearhead systems-level design and integration efforts, translating clinical and user needs into clear engineering requirements. Your expertise will help ensure design outputs align with performance and regulatory standards, making a significant impact in delivering safe and innovative medical technologies. Ideal candidates will thrive in a collaborative environment, working alongside cross-functional teams in electrical, mechanical, software, and clinical domains.

Key Responsibilities

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

Qualifications

Preferred Qualifications