Role & responsibilities

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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.

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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.
- 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. 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.

Essential • 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 workplace.
- Experience maintaining compliance with medical device quality management systems and regulatory frameworks. Desirable • 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.

📌 Biomedical Engineer (Visakhapatnam)
🏢 Virgil Healthcare
📍 Visakhapatnam