Lead System Designer - Anesthesia workstation

About the CompanyBPL 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 - SummaryThis 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 ResponsibilitiesSystem Architecture & Design LeadershipDefine 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 IntegrationCollaborate 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 ComplianceEnsure 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 & ValidationDefine 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 & MentoringMentor 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 ForQualifications & Experience12+ 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 & CompetenciesSystems 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 leadershipPneumatics, gas delivery, and embedded systems integration.Why This Role MattersThis 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

Apply Now