Senior Manager Application and Solution Architect – Medical & Healthcare (f/m/d)

Renesas Electronics • Houston, TX

4d • Hybrid

About The Position

We are seeking a skilled and visionary System Architect to lead the definition and development of semiconductor-based system solutions for medical and healthcare applications. In this role, you will bridge medical regulatory requirements, healthcare user experience needs, and semiconductor technology to create safe, connected, and energy-efficient systems for both regulated medical devices and consumer health/wellness products. You will collaborate closely with engineering, regulatory, and customer teams to accelerate innovation in medical-grade electronics, connected diagnostics, and digital health solutions.

Requirements

• Master’s or Ph.D. in Electrical Engineering, Biomedical Engineering, or related field
• 12+ years of experience in embedded system development for medical devices or consumer health electronics
• Proven expertise in sensor integration (bioelectrical, optical, biochemical, mechanical)
• Proven expertise in safety-critical embedded architectures and power management
• Proven expertise in wireless connectivity and secure data transmission
• Proven expertise in medical standards (IEC 60601, IEC 62304, ISO 13485, ISO 14971) and data privacy regulations (GDPR/HIPAA)
• Proven experience managing and developing small technical teams, including mentoring, performance feedback, and team coordination.
• Strong proficiency in system-level modeling and simulation (Simulink, SPICE, SystemC, PLECS)
• Excellent stakeholder alignment and cross-functional collaboration skills

Nice To Haves

• Experience in AI/ML for health signal processing or digital biomarkers
• Familiarity with cloud-connected health ecosystems (FHIR/HL7)
• Knowledge of battery-powered wearable platforms and ultra-low-power design
• Understanding of human factors and usability in healthcare device design

Responsibilities

• Architect end-to-end system platforms for medical devices (regulated) and healthcare/wellness products (non-regulated).
• Define HW/SW partitioning, secure embedded architectures, sensor interfaces, low-power data acquisition, and edge AI/analytics.
• Integrate wireless connectivity (BLE, Wi-Fi, NFC) and secure data handling for cloud-connected health systems.
• Ensure cybersecurity, patient privacy (GDPR/HIPAA), and functional safety are designed in from the start.
• Ensure designs meet regulatory standards (IEC 60601, IEC 62304, ISO 13485 for medical; CE/FCC/EMC for healthcare).
• Support risk management (ISO 14971), safety architecture reviews, and design validation.
• Coordinate with regulatory and quality teams to prepare documentation for certifications and audits.
• Lead and mentor a small team of system architects, providing technical guidance, prioritization, and people development.
• Deliver system requirement documents (SRDs), reference designs, evaluation boards, and PoCs for health-related applications.
• Work closely with product lines, firmware, analog, sensor, and connectivity teams to build cohesive solutions.
• Track emerging trends in healthtech (remote monitoring, AI-based diagnostics, digital therapeutics) and influence product roadmaps.
• Collaborate with universities, startups, and medical ecosystem partners on advanced development projects.

Benefits

• Competitive salary
• Flexible working models
• International career growth opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior