Senior Manager Application and Solution Architect - Medical & Healthcare (f/m/d)
External
Renesaselectronics · Austin, TXFull-timeOn-site1mo ago
ComplianceCross-functional CollaborationDocumentationFHIRGDPRHIPAA
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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
- 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)
- Safety-critical embedded architectures and power management
- Wireless connectivity and secure data transmission
- 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
Requirements
- 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
Benefits
Opportunity to shape the future of safe, connected, and personalized health systemsFlat hierarchies, strong technical ownership, and cross-functional collaborationDirect impact on product strategy, healthcare innovation, and patient outcomesCompetitive salary, flexible working models, and international career growth opportunitiesWith a diverse team of over 21,000 professionals in more than 30 countries, we continue to expand our boundaries to offer enhanced user experiences through digitalization and usher into a new era of innovation. We design and develop sustainable, power-efficient solutHealth insuranceVision insuranceRemote work optionsFlexible schedule
Additional Information
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.
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