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 transparent 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 meetings.
- Define and champion systems engineering best practices across the organisation.

Preferred candidate profile

Qualifications & Experience

- 12+ years in medical device system design, with at least 5 years in a lead role on anaesthesia devices.
- Proven experience with Class II or Class III medical devices.
- Solid working knowledge of anaesthesia/respiratory systems gas mixing, vaporizers, ventilators, patient monitoring.
- B.E. / B.Tech / M.Tech in Electronics, Electrical, or Mechanical Engineering.
- Familiarity with closed-loop anaesthesia delivery, ALM tools, or a patent/publication history is a plus.

Skills & Competencies

- Systems Engineering & MBSE
- Regulatory compliance — IEC 60601, ISO 14971, IEC 62366, FDA/CE MDR
- Risk management — FMEA, FTA, hazard analysis
- Design review facilitation (PDR, CDR, SRR)
- V&V; strategy and test planning
- Cross-functional team leadership
- Pneumatics, gas delivery, and embedded systems integration.

📌 Lead System Designer (Bengaluru)
🏢 BPL
📍 Bengaluru