Hardware Architect

About the Company

ZEISS is a global leader in optics and optoelectronics, committed to innovation and excellence in the development of medical devices. Our mission is to enhance the quality of life through advanced technology and solutions that improve patient outcomes. We foster a culture of collaboration, diversity, and continuous improvement, ensuring that our teams are empowered to drive impactful change.

About the Role

The role involves leading the design and development of embedded hardware systems for medical devices, ensuring optimal performance, power efficiency, and system integration. You will be responsible for defining scalable and reliable hardware architectures while collaborating with cross-functional teams to meet product requirements.

Responsibilities

Hardware Architecture & System Design

• Define and evolve scalable, reliable, and maintainable hardware architectures for medical devices.
• Lead the design and development of embedded hardware systems, ensuring optimal performance, power efficiency, and system integration.
• Develop system-level architectures covering electronics, embedded platforms, sensors, optical interfaces, and connectivity.
• Ensure seamless interaction between hardware, embedded software, and higher-level application systems.

Electrical Design and Development

• Design and validate complex electrical systems including:
• Analog circuits (signal conditioning, sensor interfacing, power management)
• Digital systems (microcontrollers, processors, communication interfaces)
• Develop schematics, PCB layouts (in collaboration with design teams), and perform design reviews.
• Ensure compliance with relevant standards (EMC, safety, regulatory requirements).
• Drive hardware bring-up, debugging, and root cause analysis during development and field issues.

Embedded Systems and Integration

• Define and support embedded architecture, including processor selection, interfaces, and HW-SW partitioning.
• Work closely with software teams to ensure efficient hardware-software integration.
• Enable reliable communication between sensors, actuators, and processing units.
• Ensure system performance, real-time behavior, and diagnostic capabilities.

Mechanical Interface Understanding

• Collaborate with mechanical engineering teams on device integration.
• Ensure compatibility of hardware designs with:
• Sheet metal components
• Plastic enclosures and assemblies
• Consider thermal management, structural constraints, manufacturability, and serviceability.

Cross-Functional Product Development

• Work closely with product management, systems engineering, optics, usability, quality, and manufacturing teams.
• Translate clinical, customer, and business requirements into hardware specifications and designs.
• Ensure alignment with system architecture and product timelines.
• Support system-level integration and validation activities.

OEM Interaction and Customization

• Collaborate with OEM partners for hardware module sourcing, customization, and integration.
• Define technical requirements and specifications for OEM-supplied components.
• Support OEM qualification processes, including design reviews, validation, and compliance checks.
• Ensure OEM deliverables meet ZEISS standards for quality, reliability, and regulatory compliance.
• Drive issue resolution and continuous improvement with OEM partners.

Value Engineering & Cost Optimization

• Apply a strong value engineering mindset to optimize product cost without compromising quality, performance, or compliance.
• Identify cost drivers in hardware design and proactively drive design-to-cost initiatives.
• Evaluate alternative components, materials, and design approaches to achieve optimal cost-performance balance.
• Collaborate with sourcing, manufacturing, and OEM partners to achieve cost targets across the product lifecycle.

Quality, Compliance, and Documentation

• Ensure adherence to medical device development processes and regulatory standards.
• Support risk management activities (e.g., hazard analysis, FMEA).
• Maintain high standards for documentation, traceability, and configuration management.
• Ensure hardware design supports product reliability, diagnostics, and long-term serviceability

Qualifications

• Bachelors or Masters degree in Electronics Engineering, Electrical Engineering, Biomedical Engineering, or related field.
• Typically 12+ years of experience in hardware engineering, preferably in medical devices or regulated industries.
• Proven experience in developing complex embedded hardware systems across the product lifecycle.
• Experience working in cross-functional and global development environments.

Required Skills

• Strong expertise in embedded hardware architecture and system design.
• Deep knowledge of Analog design (signal conditioning, ADC/DAC, power circuits)
• Value engineering in hardware engineering
• Digital design (microcontrollers, processors, FPGA is a plus)
• Experience in electrical design, schematic development, and hardware validation.
• Solid understanding of hardware-software integration and embedded systems.
• Familiarity with communication protocols (SPI, I2C, UART, Ethernet, etc.).
• Understanding of mechanical integration, including sheet metal and plastic components.
• Knowledge of regulatory and compliance standards in medical device development.
• Strong troubleshooting, debugging, and problem-solving skills.
• Good knowledge in EMC, safety standards, and reliability engineering.

Preferred Skills

• Stakeholder Engagement & Global Collaboration
• Partner with global R&D, quality, regulatory, service, manufacturing, and product teams.
• Translate product strategies into scalable and support