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.

Responsibilities:

• 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.

Required Qualifications:

• 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

Preferred Qualifications:

• 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