About the job

Company Description:

At Capla, we are redefining the future of surgery through intelligent, connected, and data-driven medical technologies. Our mission is to make surgery smarter, safer, and more human-centered by combining AI, machine learning, cloud computing, and advanced visualization systems.

We are developing next-generation surgical navigation and OR integration platforms that empower surgeons with precision, real-time insights, and intuitive control—ultimately improving patient outcomes worldwide.

Capla’s strength comes from its multidisciplinary team of healthcare professionals, surgeons, robotic and biomedical engineers, AI and ML specialists, quality experts, and data scientists. Together, we are building technologies that bring intelligence, accuracy, and trust to every step of the surgical workflow.

As an early and rapidly growing healthcare startup, Capla offers an exciting environment for those who want to contribute directly to products shaping the future of modern surgery.

Job ID: CV26003

Department: R&D; – Verification & Validation

Reports to: R&D; / System Engineering Lead

Location: Bangalore / Hybrid

Employment Type: Full-time (100%)

Position Summary

As a Testing Engineer, you will be responsible for verification and validation of Capla’s surgical navigation and medical technology platforms, ensuring that software, hardware, and integrated system functionality meet defined product, clinical, safety, performance, quality, and regulatory requirements.

You will work closely with software, hardware, systems, clinical, and Quality & Regulatory teams to develop and execute structured testing throughout the medical device development lifecycle.

The role requires a strong understanding of medical device testing protocols, verification and validation, regulatory requirements, traceability, risk management, and controlled documentation.

Responsibilities

Verification & Validation

- Develop, review, and execute verification and validation plans, protocols, test cases, and reports
- Perform testing according to approved procedures, acceptance criteria, and Capla’s Quality Management System
- Perform functional, integration, system, regression, performance, reliability, accuracy, and safety-related testing
- Verify product functionality against approved user, system, software, and product requirements
- Conduct end-to-end testing of surgical navigation workflows and clinical use cases
- Support verification of software, hardware, imaging, tracking, instruments, and peripheral integrations
- Perform negative, edge-case, fault-condition,



and abnormal-use testing
- Support simulated-use and clinically representative system testing

Software & System Testing

- Test applications running on Linux / Embedded Linux platforms
- Validate integration between software modules, hardware components, sensors, tracking systems, imaging systems, and external devices
- Perform interface, API, connectivity, and data-flow testing
- Conduct installation, configuration, upgrade, recovery, and restart testing
- Test system alerts, logging, data integrity, error handling, and failure-recovery mechanisms
- Support accuracy, repeatability, latency, calibration, registration, and system-performance testing where applicable

Medical Device Testing Protocols

- Translate product and system requirements into structured, measurable test cases
- Define test prerequisites, methods, expected results, acceptance criteria, and objective evidence
- Execute approved test protocols and document deviations according to QMS procedures
- Maintain complete test records, logs, measurements, screenshots, and supporting evidence
- Ensure testing is repeatable, traceable, and suitable for regulatory review
- Document failed tests, anomalies, and deviations and ensure appropriate investigation and re-testing

Test Automation & Defect Management

- Develop and maintain automated test scripts for regression and functional testing
- Use tools such as Python for test automation, data analysis, and test utilities
- Support CI/CD and automated testing environments
- Analyse logs, test outputs, and performance data to identify root causes of failures
- Identify, document, reproduce, classify, and track software and system defects
- Verify bug fixes and perform regression testing
- Support root cause analysis and corrective actions

Regulatory, Quality & QMS

- Work according to Capla’s ISO 13485-based Quality Management System
- Support compliance with applicable standards including IEC 62304, ISO 14971, IEC 62366-1, IEC 60601 series, EU MDR 2017/745, and FDA Quality System requirements
- Understand the relationship between user needs, system requirements, software requirements, identified risks, verification activities, and regulatory evidence




- Support verification of risk-control measures defined through risk-management activities
- Participate in design reviews, risk reviews, verification reviews, and release-readiness reviews
- Support Quality & Regulatory teams during audits, inspections, regulatory submissions, and technical documentation preparation
- Follow applicable design-control, document-control, change-control, non-conformance, and CAPA processes

Documentation & Traceability

- Prepare and maintain test protocols, test reports, verification evidence, and deviation reports
- Maintain end-to-end requirement-to-test traceability
- Support maintenance of Requirements Traceability Matrices
- Ensure testing documentation is complete, version-controlled, reviewed, approved, and audit-ready
- Support software and system release documentation
- Provide verification evidence required for Design History Files and regulatory technical documentation

Qualifications

- Bachelor’s or Master’s degree in Computer Science, Electronics, Biomedical Engineering, Mechatronics, Medical Technology, or related field
- 3+ years of experience in software testing, system testing, verification, validation, or medical device testing
- Strong understanding of software and system testing methodologies
- Experience developing and executing structured test protocols and test cases
- Experience with functional, integration, regression, system-level, and performance testing
- Experience working with Linux-based systems
- Ability to analyse logs, reproduce defects, and troubleshoot complex systems
- Solid analytical, documentation, and problem-solving skills

Preferred

- Experience in medical device verification and validation
- Understanding of ISO 13485, IEC 62304, ISO 14971, IEC 62366-1, IEC 60601, EU MDR, and FDA medical device requirements
- Experience working within an ISO 13485 Quality Management System
- Experience preparing regulatory or audit-ready verification documentation
- Experience with requirement management and traceability tools
- Experience with Python or other test automation frameworks
- Familiarity with Jira, Git, CI/CD pipelines, and test management tools
- Experience testing hardware-software integrated products
- Exposure to surgical navigation, medical imaging, robotics, tracking systems, computer vision, DICOM, or 3D visualization
- Experience with design controls, risk management, CAPA, and change-control processes
- If interested, please reply with the Job ID in the subject line, along with your updated CV, current notice period, and expected compensation to [email protected].

📌 Software Testing Engineer - Medical Devices (Bengaluru)
🏢 Capla
📍 Bengaluru