Digital Health Solutions
Website:
digitalhealthsolutionsllc.com
Company:
https://www.linkedin.com/company/digital-health-sol
Seniority: Entry level
Industries: Medical Equipment Manufacturing
Job details:
Job Description: Principal Lead Verification & Validation Engineer
Location: Thane, Maharashtra
Company Overview:
Digital Health Solutions is a premier consulting company dedicated to providing comprehensive solutions to medical device companies. We specialize in helping our clients navigate the complexities of IEC 62304 and ISO 13485 compliance. Our team of skilled professionals is committed to delivering the highest level of service, ensuring that our clients' products are both safe and effective for their end users.
We are currently seeking a talented Principal Verification and Validation Engineer to join our dynamic team. This is a Principal-level role, and the ideal candidate will bring strong, hands-on experience in medical device development and Verification & Validation — along with a deep understanding of medical device processes, risk management, quality systems, design controls, and Software as a Medical Device (SaMD) development. The candidate will be expected to act as a subject matter expert (SME) on medical device processes in addition to bringing strong technical testing and V&V experience.
Job Description:
Biovantage is looking for a Principal Verification and Validation Engineer to perform end-to-end software/firmware verification and validation for our various Medical Device and Software as a Medical Device (SaMD) product development project. As a Principal-level engineer, you will act as a subject matter expert on medical device development processes, risk management, quality systems, and regulatory requirements, in addition to leading hands-on V&V work.
You will be actively involved in understanding/authoring the software/firmware requirements, developing test protocols, executing test cases, and creating reports. You will continuously track software bugs and control the overall quality of the software and firmware, while providing SME-level guidance on design controls, risk management, and compliance to the broader team.
Required Skills:
• 10-15 years of hands-on experience in system/software/firmware verification and validation, with strong, hands-on experience specifically in medical device development — including system, software, firmware, integration, and product-level V&V, and a good understanding of the complete medical device product development lifecycle.
• Experience developing and reviewing V&V plans, protocols, procedures, test cases, reports, and traceability.
• Strong understanding of Medical Device Design Controls and Design History File (DHF) documentation, including experience reviewing or generating Product/System Requirements, Software Requirements Specifications, Design Specifications, Verification Plans/Protocols/Reports, Validation Plans and Reports, Requirements Traceability Matrix, and Engineering/Technical Reports.
• Understanding of the relationship between requirements → design → risk controls → verification → validation → DHF.
• Strong knowledge and hands-on experience with Medical Device Risk Management per ISO 14971, including dFMEA/FMEA, software/system risk analysis, and risk-control verification and traceability; knowledge of Fault Tree Analysis (FTA) is desirable.
• Good understanding of ISO 13485 and Medical Device QMS, with experience working within a regulated quality system; understanding of document control, change control, CAPA/deviation processes, and quality records is desirable.
• Experience with Software as a Medical Device (SaMD) and/or software embedded within medical devices, with a strong understanding of IEC 62304 and SDLC within a regulated environment, including software requirements, architecture/design, software V&V, configuration management, and release processes.
• Hands-on testing experience across Embedded Software/Firmware, Mobile, Web, and Cloud Applications/Services, System Integration, System-Level, Performance, Regression, and Interface/API testing.
• Good understanding of Medical Device Cybersecurity, including FDA cybersecurity guidance, threat modeling, security risk management, and verification of cybersecurity requirements within the medical-device lifecycle; experience with penetration/security testing is highly desirable.
• Strong track record of technical leadership in cross-functional, deadline-driven environments, with project management skills (planning and estimation of tasks and milestones) and excellent problem-solving ability, working independently or as part of a team.
• Strong written and verbal communication skills, with the ability to effectively convey complex technical concepts to non-technical stakeholders.
Preferred Skills:
• Familiarity with requirements management tools, configuration management tools and test management tools like Git, TestRail, Jira, Helix/TestTrack, Confluence, etc.
Responsibilities:
• Act as a subject matter expert on medical device development processes, risk management (ISO 14971), quality systems (ISO 13485), design controls, and SaMD/IEC 62304 requirements — advising the team and clients as needed.
• Participate in the development of system and subsystem requirements development and review.
• Lead and contribute to verification and validation of a Medical Device product's hardware and software, including but not limited to development of verification plans, review of system and subsystem requirements, design of test strategies and methods, writing and executing test cases, generating traceability reports, and generating test execution reports.
• Collaborate with product development teams to understand the product specification, system interfaces, operational requirements, performance requirements, software requirements, software design, etc., to discuss and review test methods and test strategies.
• Manage technical and schedule balance while coordinating with the project manager and functional leads to ensure the planned approach meets schedule constraints.
• Perform hands-on system integration testing and troubleshooting technical issues across firmware, cloud, and application layers.
• Perform system-level verification against requirements. Create test plans, procedures and reports; perform and analyse system set-up; conduct verification and validation activities.
• Mentor fellow V&V engineers and work to foster an environment of individual development and organizational growth.
• Help grow the organization by participating in the interview process for engineers of various disciplines, working closely with senior leadership.
• Stay current with industry trends, regulatory guidance, standards, and best practices in the medical device industry to continuously improve our services and maintain our competitive edge.
Click on Apply to know more.
