Lead System Designer - Anaesthesia

BPL Medical Technologies; Bengaluru; On-site; INR 4,500,000 - 6,500,000; Full time

Job summary

BPL Medical Technologies, a leading Indian medical technology company, seeks a Lead System Designer for the Anaesthesia Workstation to drive end-to-end system architecture across hardware, embedded software, pneumatics, and user interfaces. You will work at the intersection of disciplines to deliver safe, regulatory-compliant workstations for critical care settings.

The role requires 12+ years in medical devices with leadership experience, strong familiarity with IEC 60601 and ISO 14971, and

Qualifications

• 12+ years in medical device system design; 5+ years in lead roles.
• Demonstrated experience with Class II/III medical devices.
• Strong knowledge of anaesthesia/respiratory systems.
• Experience with IEC 60601 series, ISO 14971, IEC 62366 (Usability).
• Hands-on system-level FMEA, fault trees, and risk assessment tools.
• BE/B.Tech/MTech in Electronics, Electrical, or Mechanical Engineering.

Responsibilities

• Define and own the system architecture for the anaesthesia workstation.
• Lead trade-off analyses across subsystems and document design decisions.
• Develop and maintain the SRS, SDS, and ICD documents.
• Drive modular system decomposition to enable parallel sub-team development and integration.
• Collaborate with mechanical, electrical, embedded software, and clinical affairs teams.
• Define and manage internal and external interfaces between subsystems.
• Coordinate with Supply Chain and Procurement for components.
• Maintain up-to-date knowledge of product maintenance and end-of-life considerations.
• Lead design reviews (PDR, CDR, SRR) and facilitate problem-solving sessions.
• Mentor engineers across hardware, software, and systems disciplines.
• Support regulatory submissions with technical rationale and evidence packages.

Skills

System design

Medical devices

Regulatory compliance

Risk assessment

FMEA

FTA

Leadership

Mentoring

Documentation

Embedded systems

V&V

Stakeholder engagement

Education

BE/BTech/MTech in Electronics/Electrical/Mechanical Engineering

Tools

ALM tools

FMEA tools

Job description

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

The Lead System Designer for the Anaesthesia Workstation is a senior technical leadership role responsible for driving end-to-end system architecture, design, and integration of anaesthesia delivery platforms. The incumbent will work at the intersection of hardware, embedded software, pneumatics, and user experience to deliver safe, reliable, and regulatory-compliant anaesthesia workstations.

Key Responsibilities

• Define and own the system architecture for the anaesthesia workstation, including gas delivery, ventilation, monitoring, and user interface subsystems.
• Lead trade-off analyses (functional, performance, safety, cost) across all subsystems and document design decisions.
• 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 integration.

Cross-Functional Integration

• Collaborate with mechanical, electrical, embedded software, and clinical affairs teams to ensure cohesive system-level design.
• Define and manage internal and external interfaces between subsystems (gas circuits, sensors, displays, alarms, communications).
• Coordinate with Supply Chain and Procurement for critical component selection and validation.
• Maintain up-to-date knowledge of product maintenance and end-of-life considerations.

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 design documentation in support of the Design History File (DHF) and Technical Files.
• Support regulatory submissions with technical rationale and evidence packages.

Verification & Validation

• Define system-level V&V strategy and test plans in alignment with design inputs and intended use.
• Lead system-level bench testing, integration testing, and clinical simulation activities.
• Support design transfer activities 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 best practices for systems engineering methodology within the organization.

What We’re Looking For

Qualifications & Experience

• 12+ years of system design experience in medical devices, with at least 5 years preferably in a lead/principal role developing anaesthesia devices.
• Demonstrated experience with Class II or Class III medical devices.
• Strong working knowledge of anaesthesia or respiratory systems (gas mixing, vaporizers, ventilators, patient monitoring).
• Experience with the IEC 60601 series, ISO 14971, and IEC 62366 (Usability Engineering).
• Hands-on experience with system-level FMEA, fault trees, and risk assessment tools.
• B.E./B.Tech/M.Tech in Electronics, Electrical, or Mechanical Engineering.

Preferred Qualifications

• Familiarity with closed-loop anaesthesia delivery or automated drug delivery systems.
• Working knowledge of requirements management and ALM tools.
• Publication or patent history in relevant technical domains is a plus.
• Deep anaesthesia/respiratory device knowledge.
• Regulatory compliance expertise (FDA, CE, ISO).
• V&V strategy and test design.
• Pneumatics and gas delivery systems knowledge.
• Embedded systems integration.
• Cross-functional team leadership and stakeholder/executive engagement.
• Structured communication, documentation, and design review facilitation.
• Mentoring and coaching engineers.
• Problem-solving under constraints, with clinical and end-user empathy.

Why This Role Matters

You'll own the system-level architecture of a device that clinicians depend on in some of the most critical moments in an operating room, gaining:

• End-to-end ownership of system architecture across hardware, software, and pneumatics for a complex, safety-critical platform.
• A senior technical leadership seat, representing the systems team at executive design reviews and steering committees.
• The opportunity to mentor and grow engineers across multiple disciplines.
• The chance to work in a company with real purpose — where rigorous systems engineering translates directly into safer anaesthesia delivery.