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

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.   Key Responsibilities System Architecture & Design • Architect end-to-end system platforms for: • Medical devices (regulated): glucose meters, blood pressure monitors, ECG, hearing aids, portable diagnostic or therapeutic devices. • Healthcare/wellness products (non-regulated): wearables, fitness trackers, sleep and activity monitors, smart scales. • 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.  Compliance & Quality • 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.  Strategic & Cross-functional Collaboration • 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.  Success Metrics & KPIs • # of Reference Architectures Delivered for medical and healthcare systems • # of Design-in Wins Influenced and associated revenue pipeline • First-pass Certification Success Rate for regulated devices • System Power Efficiency Improvement vs. prior designs • Avg Time-to-PoC from concept to validated prototype • Customer Satisfaction Score from medtech and healthcare partners • % of Solutions Passing Security & Privacy Compliance Audits • # of Engineers Trained internally on medical/healthcare system design