BPL Medical Technologies
Website:
bplmedicaltechnologies.com
Job details:
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
We are seeking an experienced, full-time Lead Hardware Engineer to own the design, development, and continuous improvement of defibrillator electrode lead systems for external/AED (Automated External Defibrillator) applications. This role combines hands-on technical leadership with team coordination, guiding a small group of engineers through the full product lifecycle — from concept and requirements definition through verification, validation, and regulatory submission.
You will be the technical backbone of lead system design efforts, balancing electrical, mechanical, and biocompatibility requirements while ensuring designs meet stringent safety and regulatory standards (IEC 60601, ISO 13485, FDA 510(k)/PMA pathways).
Key Responsibilities
Lead System Design & Engineering
- Lead the end-to-end design of external defibrillator electrode/lead systems, including pad electrodes, connector interfaces, cabling, and impedance-matching components.
- Translate clinical and user requirements into detailed engineering specifications for lead system performance (energy delivery, impedance range, adhesion, durability, biocompatibility).
- Evaluate and select materials, adhesives, and conductive components for optimal electrical performance, patient safety, and shelf-life stability.
Power Electronics & Critical Component Engineering
- Apply power electronics expertise to ensure lead system compatibility with high-voltage discharge circuits, including energy delivery pathways, charge/discharge behaviour, and impedance matching between the defibrillator's output stage (capacitor bank, H-bridge/IGBT switching network) and the patient/electrode interface.
- Own critical component selection and qualification for the lead system, including connectors, cabling, conductive adhesives/gels, and interface circuitry — evaluating each for electrical performance, failure modes, derating margins, and long-term reliability under repeated high-energy discharge.
- Partner with electrical engineering on system-level analysis of energy delivery accuracy, leakage current, and defibrillation waveform integrity (biphasic/monophasic) as influenced by lead and electrode design.
- Support component-level risk assessments (e.g., single-fault conditions, worst-case stress analysis) for critical components in the discharge path, in line with IEC 60601-1 and IEC 60601-2-4 safety requirements.
Verification, Validation & Risk Management
- Drive design verification and validation (V&V) activities, including test protocol development, bench testing, and simulated-use studies.
- Support risk management activities (FMEA, hazard analysis) in accordance with ISO 14971.
- Investigate and resolve field complaints, CAPAs, and design-related nonconformances related to lead systems.
Regulatory & Quality Documentation
- Prepare and review design history file (DHF) documentation to support regulatory submissions (FDA, CE/MDR).
Team Leadership & Cross-Functional Collaboration
- Guide and mentor a team of design/electrical/mechanical engineers, reviewing designs, providing technical direction, and ensuring milestones are met.
- Collaborate cross-functionally with R&D, Quality, Regulatory Affairs, Manufacturing, and Clinical teams to ensure designs are manufacturable, testable, and compliant.
Market & Technology Awareness
- Stay current with industry standards, competitive products, and emerging technologies in external defibrillation and electrode design.
What We’re Looking For
Qualifications & Experience
- Bachelor's degree in Electronics & Communication, Electrical Engineering, or a related field (Master's preferred).
- 10+ years of experience in medical device design, with direct experience in defibrillator, electrode, or lead system development.
- Demonstrated experience leading design projects and mentoring or informally managing engineers.
- Experience with design controls under ISO 13485 / FDA QSR (21 CFR 820).
Technical Skills
- Strong understanding of electrical safety standards (IEC 60601-1, IEC 60601-2-4) and biocompatibility requirements (ISO 10993).
- Hands-on experience with electrode/lead materials (conductive gels, hydrogels, adhesives, connectors) and their electrical/mechanical characterization.
- Solid working knowledge of power electronics as applied to defibrillation systems, including high-voltage capacitor discharge circuits, IGBT/H-bridge switching topologies, energy storage and delivery, and biphasic waveform generation.
- Strong critical-component understanding: ability to identify, specify, and qualify components in the high-energy discharge path (capacitors, switching elements, connectors, cabling) based on voltage/current ratings, derating, thermal behaviour, and failure-mode risk.
- Proficiency with CAD tools (SolidWorks or equivalent), circuit simulation tools (e.g., SPICE), and electrical/high-voltage test equipment.
- Excellent written and verbal communication skills, with experience authoring technical documentation for regulatory submissions.
Preferred Qualifications
- Experience with AED-specific design challenges (single-use pad longevity, paediatric/adult electrode variants, self-test circuitry integration).
- Familiarity with human factors/usability engineering (IEC 62366) as applied to lay-user defibrillation devices.
- Experience taking a product through FDA 510(k) clearance or international regulatory approval.
- Experience with Design for Manufacturability (DFM) and working with contract manufacturers.
Why This Role Matters
You'll be the technical backbone of a product line where design decisions have a direct, life-critical impact — shaping how a defibrillator delivers energy safely and reliably when it matters most, gaining:
- End-to-end technical ownership of a safety-critical system, from concept through regulatory submission.
- Deep, specialised exposure to power electronics, materials science, and regulatory design controls in a single role.
- A leadership platform to mentor and grow a team of design engineers.
- The chance to work in a company with real purpose — where rigorous engineering translates directly into better patient outcomes in the most critical moments.
Location - Bangalore
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