Principal Systems Architect - Medical Devices
Principal Systems Architect
Remote | India
Design the Future of Medical Technology
Are you a systems architecture leader with a passion for building innovative healthcare products? We're looking for a Principal Systems Architect to lead the technical direction of next-generation medical devices and connected healthcare solutions.
This is an exciting opportunity to shape product strategy, define system architecture, and influence complex engineering decisions from concept through commercialization. You'll work with global teams across hardware, software, firmware, cloud connectivity, quality, and regulatory functions to bring life-changing technologies to market.
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 decision-making 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.
What You'll Bring
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
Electromechanical medical devices
Hardware and electronics design
Requirements management and traceability
Risk management and 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 (MBSE).
Experience supporting FDA, CE Mark, MDR, or international regulatory submissions.
Master's degree in a relevant engineering discipline.
Success in This Role
You'll thrive if you are:
A strategic systems thinker with strong technical depth.
Highly skilled in hardware and electromechanical system design.
Comfortable making complex technical decisions and driving alignment across teams.
Able to balance technical, regulatory, manufacturing, and business requirements.
A collaborative leader who can influence without direct authority.
Passionate about building safe, reliable, and innovative healthcare products.
Why Join Us?
Work remotely from anywhere in India.
Competitive salary
Play a key role in developing technologies that improve patient care worldwide.
Influence product architecture and technical strategy at a global level.
Collaborate with highly skilled international engineering teams.
Work on cutting-edge connected medical devices and healthcare innovations.
Enjoy the opportunity to mentor engineers and shape future products.
Ready to Make an Impact?
Join us in developing the next generation of medical technology and help improve lives around the world.
Apply today and become a key architect of healthcare innovation.