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

Company Description

Job Description

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

Qualifications

• 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

Nice to Have

• 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

What We Offer

• Opportunity to shape the future of safe, connected, and personalized health systems
• Flat hierarchies, strong technical ownership, and cross-functional collaboration
• Direct impact on product strategy, healthcare innovation, and patient outcomes
• Competitive salary, flexible working models, and international career growth opportunities

Additional Information

Renesas is an embedded semiconductor solution provider driven by its Purpose 'To Make Our Lives Easier.' As the industry's leading expert in embedded processing with unmatched quality and system-level know-how, we have evolved to provide scalable and comprehensive semiconductor solutions for automotive, industrial, infrastructure, and IoT industries based on the broadest product portfolio, including High Performance Computing, Embedded Processing, Analog & Connectivity, and Power.

With 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 solutions today that help people and communities thrive tomorrow, 'To Make Our Lives Easier.'

At Renesas, you can:

• Launch and advance your career in technical and business roles across four Product Groups and various corporate functions. You will have the opportunities to explore our hardware and software capabilities and try new things.

• Make a real impact by developing innovative products and solutions to meet our global customers' evolving needs and help make people's lives easier, safe and secure.

• Maximize your performance and wellbeing in our flexible and inclusive work environment. Our people-first culture and global support system, including the remote work option and Employee Resource Groups, will help you excel from the first day.

Are you ready to own your success and make your mark?

Join Renesas. Let's Shape the Future together.

Renesas Electronics is an equal opportunity and affirmative action employer, committed to supporting diversity and fostering a work environment free of discrimination on the basis of sex, race, religion, national origin, gender, gender identity, gender expression, age, sexual orientation, military status, veteran status, or any other basis protected by law. For more information, please read our Diversity & Inclusion Statement.