Principal Systems Architect - Medical Devices
Role Overview
Natus is seeking a Principal Systems Architect to lead technical direction for next-generation medical devices and connected healthcare solutions.
The role shapes product strategy, system architecture, and complex engineering decisions from concept through commercialization.
The architect works with global hardware, software, firmware, cloud connectivity, quality, and regulatory teams.
Key Skills for This Role
Full Job Posting
Role Overview
Natus is seeking a Principal Systems Architect to lead technical direction for next-generation medical devices and connected healthcare solutions.
The role shapes product strategy, system architecture, and complex engineering decisions from concept through commercialization.
The architect works with global hardware, software, firmware, cloud connectivity, quality, and regulatory teams.
Workplace
- Remote role open to candidates anywhere in India.
What You'll Do
- Define and lead system architecture for complex medical devices and connected healthcare products.
- Translate customer, clinical, business, and regulatory needs into scalable technical solutions.
- Own system-level requirements, architecture documentation, and traceability.
- Drive technical decisions across hardware, firmware, software, mechanical, and cloud-connected systems.
- Lead design reviews, architecture reviews, and technical risk assessments.
- Guide system integration, verification, and validation strategies.
- Lead risk management activities, including hazard analysis and DFMEA.
- Mentor engineers and champion systems engineering best practices across teams.
- Ensure products meet global regulatory, quality, and safety requirements.
Essential Requirements
- Bachelor's degree in Engineering, Biomedical Engineering, Systems Engineering, or a related discipline.
- 10+ years of experience developing regulated medical devices.
- 5+ years in a Systems Architect, Lead Systems Engineer, or similar technical leadership role.
- Proven experience delivering products from concept through commercialization.
- Deep understanding of systems engineering and architecture development.
- Deep understanding of electromechanical medical devices, hardware and electronics design, requirements management, and traceability.
- Deep understanding of risk management, reliability engineering, design controls, verification, and validation.
- Experience leading technical decisions across multidisciplinary engineering teams.
Nice to Have
- Experience with neurodiagnostics, patient monitoring, imaging, surgical, wearable, or connected medical devices.
- Knowledge of cloud-connected solutions, embedded software, mobile applications, and cybersecurity.
- Experience with Jama, DOORS, Polarion, Jira, Enterprise Architect, Cameo, or similar tools.
- Exposure to Model-Based Systems Engineering.
- Experience supporting FDA, CE Mark, MDR, or international regulatory submissions.
- Master's degree in a relevant engineering discipline.
Why Join Us
- Develop technologies intended to improve patient care worldwide.
- Influence product architecture and technical strategy with international engineering teams.
- Mentor engineers and help shape future products.
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