Lead System Designer - Anesthesia workstation

About the Company

BPL Medical Technologies is a leading Indian medical technology company committed to advancing healthcare through innovative, reliable, and accessible solutions. With a strong legacy and nationwide presence, BPL serves hospitals, clinics, and healthcare providers across India and select international markets.

The company offers a diverse portfolio across patient monitoring, imaging, and critical care, supported by robust manufacturing, service, and distribution capabilities. With a growing installed base and a focus on quality and customer trust, BPL continues to strengthen its position as a trusted partner in healthcare delivery.

Driven by innovation and operational excellence, BPL is focused on building future-ready capabilities and delivering long-term value to customers, partners, and stakeholders.

Get to know about us - https://www.bplmedicaltechnologies.com/

Role Summary

This is a senior technical leadership role in one of our most critical product lines. As Lead System Designer for the Anaesthesia Workstation, you'll own end-to-end system architecture, design, and integration of our anaesthesia delivery platforms — working at the intersection of hardware, embedded software, pneumatics, and clinical user experience.

Key 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 clear 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.

What We’re Looking For

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.

Why This Role Matters

This is a high-impact, high-visibility role for a seasoned systems engineer who is ready to take full ownership of a life-critical medical device.

• You will own the end-to-end system architecture of a life-critical medical device, with full accountability and leadership visibility.
• The role offers rare technical breadth across pneumatics, electronics, embedded software, and clinical user experience within a single platform.
• You will develop deep, cross-jurisdictional regulatory expertise across FDA, CE MDR, and ISO standards — a highly valued competency in the global medical device industry.
• You will lead, mentor, and shape engineers across disciplines, directly influencing the engineering culture of the team.
• Your work will have a direct and measurable impact in clinical environments where precision and reliability are non-negotiable.

Location - Bangalore