Role & responsibilities
System Architecture & Design Leadership
- Define and own the system architecture for the anaesthesia workstation spanning gas delivery, ventilation, monitoring, and user interface subsystems.
- Lead trade-off analyses across all subsystems (functional, performance, safety, cost) and document every key design decision.
- Develop and maintain the System Requirements Specification (SRS), System Design Specification (SDS), and Interface Control Documents (ICD).
- Drive modular system decomposition to enable parallel sub-team development and seamless integration.
Cross-Functional Integration
- Collaborate closely with mechanical, electrical, embedded software, and clinical affairs teams to ensure a cohesive system-level design.
- Define and manage interfaces between subsystems gas circuits, sensors, displays, alarms, communications.
- Partner with Supply Chain and Procurement for critical component selection and validation.
Regulatory & Safety Compliance
- Ensure design compliance with IEC 60601-1, ISO 80601-2-13, ISO 14971, IEC 62133,
and applicable FDA/CE MDR requirements.
- Lead system-level risk management activities including FMEA, FTA, and hazard analyses.
- Author and review technical documentation in support of the Design History File (DHF) and Technical Files.
- Support regulatory submissions with explicit technical rationale and robust evidence packages.
Verification & Validation
- Define the system-level V&V; strategy and test plans, aligned with design inputs and intended use.
- Lead system-level bench testing, integration testing, and clinical simulation activities.
- Support design transfer and manufacturing process validation (IQ/OQ/PQ).
Technical Leadership & Mentoring
- Mentor junior and mid-level engineers across hardware, software, and systems disciplines.
- Lead design reviews (PDR, CDR, SRR) and facilitate structured problem-solving sessions.
- Represent the systems team in steering committee and executive design review meeti
📌 Lead System Designer (Bengaluru)
🏢 BPL
📍 Bengaluru