Bioscan Research
Website:
bioscanresearch.com
Job details:
About the Company:
Bioscan Research Pvt. Ltd. is a medical-device technology company developing innovative solutions using photonics, sensing, electronics and data science to improve patient outcomes. Its flagship product, CEREBO®, is a portable, non-invasive NIRS-based system for rapid assessment of intracranial bleeding in traumatic brain injury. Bioscan is an ISO 13485:2016 certified organization focused on developing and commercializing next-generation medical technologies.
About the Role:
We are looking for a Product Verification & Integration Engineer to take responsibility for system integration, product testing, verification and controlled release of Bioscan's medical devices. The role will involve working across hardware, sensors, firmware, software and mechanical systems to ensure that products meet defined requirements and are ready for production and deployment.
The role will also be responsible for maintaining test, verification and quality documentation in accordance with the Bioscan QMS.
Key Responsibilities
- Integrate hardware, sensors, firmware, software and mechanical subsystems into complete products.
- Analyse requirements and develop test cases, test protocols and acceptance criteria.
- Perform functional, system, integration, regression, performance and product testing.
- Conduct Design Verification and support Design Validation activities.
- Verify sensors, device workflows, connectivity, firmware parameters and system performance.
- Identify, document and track defects; support root-cause analysis, corrective actions and retesting.
- Perform release testing and verify approved hardware, firmware and software configurations before production release.
- Support Engineering Change, Design Transfer and product release activities.
- Prepare and maintain test protocols, test reports, ATP/ATR, verification records and requirement traceability.
- Maintain relevant DHF, DHR and other quality records in accordance with the QMS.
- Support QA/QC, Production, Service, Complaints and RMA investigations through technical testing and analysis.
- Continuously improve test methods, test coverage, reliability and testing efficiency.
Skills & Experience
- Bachelor's or Master's degree in Biomedical Engineering, Electronics, Electrical, Instrumentation or a related field.
- 3–5 years of experience in medical-device testing, product verification, system integration or healthcare technology.
- Strong experience in functional, system, integration, regression and product testing.
- Experience with medical-device hardware, sensors and software/firmware integration.
- Knowledge of requirements analysis, test-case development, defect management and verification documentation.
- Experience with DHF, DHR, ATP, ATR and quality documentation.
- Working knowledge of ISO 13485, IEC 60601 and medical-device development processes.
- Experience with tools such as JIRA, Mantis or similar defect-management systems.
- Knowledge of SQL/API testing, DICOM, PACS, HL7 or healthcare applications is an advantage.
- Strong analytical, troubleshooting, documentation and cross-functional collaboration skills.
Click on Apply to know more.
