Principal Systems Engineer

Job Summary

The Principal Systems Engineer will lead the architecture and integration of active implantable medical devices (AIMDs). This role involves defining system-level requirements, ensuring seamless integration of electrical, mechanical, and software components, and driving compliance with stringent medical device regulations. The ideal candidate will provide technical leadership and collaborate cross‑functionally to translate clinical needs into safe, reliable, and manufacturable products.

• Define and manage system-level requirements, architecture, and interfaces for implantable devices and associated external components.
• Collect and analyze design inputs (customer needs, business needs, etc.) and transform them into high quality engineering user system requirements and product system specifications.
• Work with outside development partners to support the system design activities for development projects or programs.
• Lead, coordinate, execute, and document system analysis and design activities including but not limited to architecture definition, interface management, performance modeling, and system integration, etc.
• Develop and maintain system models, perform trade‑off analyses, and optimize constraints such as ultra‑low power, biocompatibility, miniaturization, and long‑term reliability.
• Oversee verification and validation planning at the system level, including safety testing.
• Collaborate with cross‑functional teams to support design reviews, technology roadmaps, and regulatory submissions.
• Stay current with advancements in implantable systems, including neuromodulation, and telemetry.
• Mentor junior engineers within the engineering organization and lead technical discussions to ensure robust system design and integration.

• Bachelor’s degree in Systems Engineering, Electrical Engineering, Biomedical Engineering, or related field.
• 10+ years of experience in system design, architecture and integration for active implantable medical devices (e.g., neurostimulators, pacemakers, defibrillators, cochlear implants, or similar Class II/III devices).
• Proven track record in medical device development, including full product lifecycle from concept to commercialization.
• Strong knowledge of regulatory requirements for implantable devices and experience with design controls, verification/validation, and risk management.

• Master’s or Ph.D. in Systems Engineering, Electrical Engineering or related field.
• Experience with neuromodulation, cardiac rhythm management, or closed‑loop implantable systems.
• Familiarity with system modeling tools (e.g., MATLAB/Simulink), requirements management platforms, and interface control documentation.
• Experience leading technical teams, design reviews, FMEA sessions.
• Participation in regulatory audits.