Biomedical Engineer

Virgil Healthcare

Visakhapatnam

On-site

INR 800,000 - 1,600,000

Full time

10 days ago

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Job summary

Virgil Healthcare in Visakhapatnam, India, seeks a Biomedical/Electronic Engineer to lead hardware integration of the OnSite Plus POCT system across clinical labs, wards, and remote settings.

You will install, configure, and commission analyzers and connectivity hubs, interface with LIS/HIS/EMR, and document installation records in line with ISO 13485 and IEC standards. A CBET or equivalent certification is preferred.

Qualifications

  • Bachelor’s degree in Biomedical Engineering or Electronic/Electrical Engineering.
  • CBET or equivalent biomedical equipment certification is highly advantageous.
  • 2.5–5 years of hands-on biomedical engineering experience in healthcare diagnostics or medical technology.

Responsibilities

  • Lead end-to-end hardware integration of OnSite Plus POCT system across deployment environments.
  • Install, configure, and commission hardware components per product specs and safety standards.
  • Interface hardware with middleware and LIS/HIS/EMR platforms with IT/POCT software team.
  • Develop and maintain hardware installation records and wiring schematics.
  • Perform structured preventive maintenance, calibration, and quality control checks per ISO 22870.
  • Act as escalation point for hardware faults and coordinate with OEMs for repairs.
  • Ensure compliance with medical device regulations and ISO 13485.

Skills

Hardware integration
System installation
Regulatory compliance
Documentation
Cross-functional collaboration

Education

Bachelor's degree in Biomedical/Electronic/Electrical Engineering
CBET or equivalent certification

Tools

Electrical testing equipment (multimeter, oscilloscope)
Wiring diagrams & schematics
POCT/LIS interfacing

Job description

Role & responsibilities
  • Hardware Integration & Installation
    • Lead end-to-end hardware integration of the OnSite Plus Point of Care system across deployment environments, including clinical laboratories, wards, and remote healthcare settings.
    • Install, configure, and commission all hardware components analyzers, reader units, connectivity hubs, power systems, and peripheral devices in line with product specifications and safety standards.
    • Interface hardware with middleware, LIS/HIS/EMR platforms, and network infrastructure, coordinating with the IT/POCT software team to ensure seamless end-to-end operation.
    • Develop and maintain hardware integration documentation, wiring schematics, and site-specific installation records.
  • 2. Electrical Wiring & Circuit Management
    • Design, execute, and verify all required electrical wiring associated with the OnSite Plus system, including power distribution, grounding, signal cabling, and interface connections.
    • Ensure all electrical installations comply with applicable standards (IEC 60601 series, local electrical codes, and relevant medical device regulations).
    • Inspect and certify the integrity of wiring harnesses, connectors, and junction points at initial installation and after any maintenance event.
    • Prepare and maintain as-built wiring diagrams and electrical layout drawings for all deployed systems.
  • 3. Preventive Maintenance & Servicing
    • Develop and execute a structured Preventive Maintenance (PM) schedule for all OnSite Plus hardware assets, covering mechanical, electronic, optical, and electrical sub-systems.
    • Perform routine calibration, quality control checks, and performance verification of POCT analyzers and associated hardware in accordance with manufacturer guidelines and ISO 22870.
    • Maintain a spare-parts inventory and consumables stock to minimize mean time to repair (MTTR) across the deployed fleet.
    • Manage equipment lifecycle records, service logs, and maintenance history within the asset management system.
  • Fault Diagnosis & Corrective Maintenance
    • Serve as the first-line technical escalation point for all hardware failures, alarms, or degraded performance events reported on the OnSite Plus system.
    • Apply systematic fault-isolation and root-cause analysis (RCA) techniques electrical testing, signal tracing, component-level diagnosis to identify and resolve defects promptly.
    • Utilize biomedical engineering test equipment (multimeters, oscilloscopes, analyzer simulation tools, signal generators, and calibration rigs) to characterize and correct faults.
    • Liaise with original equipment manufacturers (OEMs) and component suppliers for warranty claims, technical bulletins, and escalated repairs.
    • Document all corrective actions, test results, and resolutions in the service management system and prepare failure analysis reports for quality review.
  • 5. Quality, Safety & Regulatory Compliance
    • Ensure all hardware activities adhere to applicable medical device regulations, ISO 13485 quality management requirements, and local healthcare authority guidelines.
    • Conduct risk assessments for hardware modifications, upgrades, and new installations in line with ISO 14971.
    • Support internal and external audits by maintaining complete, accurate, and audit-ready hardware records.
    • Champion biomedical equipment safety awareness across clinical and technical staff at deployment sites.
  • 6. Stakeholder Engagement & Cross-Functional Collaboration
    • Work closely with the POCT IT/Middleware team, clinical laboratory managers, procurement, and logistics to coordinate hardware deployments and upgrades.
    • Provide technical guidance and hands-on training to clinical staff on the correct handling and operation of OnSite Plus hardware.
    • Prepare hardware status reports, KPI dashboards (uptime, MTTR, PM compliance), and escalation briefs for senior management.
    • Participate in product improvement initiatives, feeding field observations back into engineering and product development discussions.
Preferred candidate profile
Essential
  • Bachelor's degree or higher in Biomedical Engineering, Electronic Engineering, Electrical Engineering, Medical Technology, or a closely related discipline.
  • Recognized certification in biomedical equipment technology (CBET or equivalent) is highly advantageous.
  • 2.5 to 5 years of progressive, hands-on experience in biomedical engineering within healthcare diagnostics, in vitro diagnostics (IVD), or medical technology sectors.
  • Proven track record in the hardware integration, installation, and servicing of Point of Care Testing (POCT) systems, clinical analyzers, or similar medical devices.
  • Demonstrated hands-on experience performing and certifying electrical wiring for medical-grade equipment, including reading and producing wiring schematics and circuit diagrams.
  • Solid background in fault diagnosis using electronic test equipment and structured troubleshooting methodologies in a regulated healthcare environment.
  • Experience maintaining compliance with medical device quality management systems and regulatory frameworks.
Desirable
  • Post-graduate qualification or professional certification in medical device servicing, healthcare technology management, or clinical engineering.
  • Formal training in IEC 60601-1 and/or ISO 13485 / ISO 22870 standards.
  • Experience with connectivity and interfacing of POCT devices to LIS, HIS, or EMR systems.
  • Prior exposure to POCT co-ordination programs, field service engineering, or biomedical equipment management in a hospital, diagnostic laboratory, or healthcare company.
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