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Medical Device","description":"<p><strong>Position Overview:</strong></p><p>We’re seeking enthusiastic, team-oriented individuals who are excited to test innovative diabetes-care products and gain hands-on experience at one of the fastest-growing medical device companies.</p><p>The System Test Lead will be a technical expert responsible for leading Systems Engineering activities related to Verification and Validation of Client products in a regulated environment. This role leads end-to-end system verification across embedded firmware, mobile applications, and cloud services, ensuring robust integration, traceability, and compliance across the complete product ecosystem.<br>This&nbsp;position will report to the Manager, Systems Design Verification at&nbsp;Bengaluru,&nbsp;India.&nbsp;<br><strong>Responsibilities:</strong></p><ul><li>Manage all Verification and Validation activities and deliverables for New Product Development and sustaining products in accordance with&nbsp;Client’s&nbsp;Quality Management System and applicable medical-device regulations and standards.</li><li>Provide technical leadership for System Design Verification team.</li><li>Lead initiatives to advance processes and tools related to Design Verification activities according to System Engineering COE department objectives</li><li>&nbsp;Leads the development and execution of system integration, system verification and regression plan.</li><li>Develop, review, implement and maintain test strategies, test protocols, test cases, test reports and traceability matrices for system verification.</li><li>Report defects found during testing and assist in root cause analysis.</li><li>Drive the impact analysis and effort estimates</li><li>Collaborate with Systems Engineering to ensure that requirements are testable and appropriately leveled for verification with component level test teams (Hardware/Software)</li><li>Co-ordinate with project managers, system engineers and other technical leads to plan and execute project goals</li><li>Participate in regular cross-site stand-ups with the Acton&nbsp;site&nbsp;System Test engineers&nbsp;and broader project team to align priorities, communicate status and risks, and coordinate daily handoffs across time zones, including updates (progress, blockers, deviations, next steps).&nbsp;</li><li>Coordinate task&nbsp;assignment&nbsp;and prioritization with the Acton&nbsp;site&nbsp;System Test&nbsp;engineer&nbsp;and Release Leads; execute assigned verification test tasks, track progress, raise blockers early, and provide&nbsp;timely&nbsp;status updates and deliverables.&nbsp;</li><li>Work closely with System Automation Test team to optimize test coverage and test execution strategy</li><li>Define, track and report KPIs for product verification and product quality</li><li>Mentor to junior team members on topics such as sample size justification, statistical analysis, risk-based test coverage optimization</li><li>&nbsp;Manage and track product configurations including hardware, software, firmware version tracking and determine the impact due to configuration changes for System Design Verification</li></ul><p><strong>Education and Experience:</strong></p><p><strong>Minimum Requirements:</strong></p><ul><li>Bachelor’s degree in Biomedical Engineering, Software Engineering, Computer Science or an engineering related field.</li><li>Minimum of 8 years’ experience in medical device software testing, System Testing and/Product testing in a multidisciplinary project team environment or advanced degree and 2+ years of software testing, System Testing and/Product testing experience</li><li>Experience working in an Agile based Software Development environment &nbsp;</li><li>Good written and verbal communication skills including cross functional communication experience&nbsp;</li><li>Experience working with requirements management tool (Helix, Jama, and/or Polarion), quality management system, test case management tool, defect management tool is preferred</li></ul><p><strong>Preferred Skills and Competencies:</strong></p><ul><li>Test Engineering training and/or certification is a plus.</li><li>Strong technical judgement with extensive technical leadership skills.</li><li>Demonstrated capability of leading System design verification for programs on an electromechanical device.</li><li>Excellent Program Management Skills – PMP Certification a plus.</li><li>Experience guiding team/individuals to develop technical solutions to complex problems.</li><li>Sound knowledge of engineering first principals.</li><li>Strong Analytical and Problem-Solving Skills.</li><li>Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.</li><li>Demonstrated skills developing and introducing innovative FDA-regulated medical devices (Class 2 or 3) under Design Controls.</li><li>Experience with design and development processes that conform to standards such as ISO 13485, IEC 62304, IEC 60601, and ISO 14971.</li></ul><p><strong>Physical Requirements (if applicable):</strong></p><ul><li>Must be able to&nbsp;sit&nbsp;or&nbsp;stand&nbsp;for periods of time.</li><li>The person will need to be on site in the Bengaluru office at least&nbsp;3x/week; may work&nbsp;remotely&nbsp;other days.</li></ul>","employment_type":"Full-Time","industry":"","job_template":false,"country":{"name":"India","country_code":"IN","region":"Asia"},"is_job_displayable":true,"job_url":"https://talent500.com/jobs/ansrmedtechjobs/system-test-lead-medical-device-bengaluru-T500-26040","created_at":"2026-05-19T15:22:40.018155+05:30","updated_at":"2026-06-23T22:47:35.311903+05:30","title_alias_1":"System Test Lead - Medical Device","slug":"system-test-lead-medical-device-bengaluru-T500-26040","summary":null,"typical_workday":null,"what_you_offer":null,"what_you_need_to_succeed":null,"responsibilities":null,"type":null,"min_experience_years":8,"max_experience_years":12,"ctc_unit":"LPA","is_featured_job":false,"is_active":true,"job_code":"T500-26040","external_id":37939,"external_job_code":"INSSG003","is_anonymized":false,"mercurial_skills":null,"open_date":"2026-05-19T11:12:59.485077+05:30","published_at":"2026-05-19T15:22:39.254632+05:30","anonymization_needed":null,"anonymized_description":null,"xml_feed_anonymization":null,"unregistered_user_anonymization":null,"registered_user_anonymization":null,"pre_application_email_anonymization":null,"mettl_account":null,"job_table_sub_head":null,"job_table_short_desc":null,"is_remote":null,"job_video":null,"job_video_title":null,"job_video_description":null,"job_image_url":"https://wattt.s3.ap-south-1.amazonaws.com/PRODUCTION/T500-26040.png","role_summary":"<p><strong>About ANSR MedTech:&nbsp;</strong></p><p><strong>Who We Are:</strong></p><p>ANSR MedTech Capability Center is a new global innovation hub being established in India for a Fortune 100 Fastest-Growing Company&nbsp;in the&nbsp;MedTech sector. Built in partnership with ANSR, the center draws on ANSR’s proven experience in establishing and scaling high-performance Global Capability Centers (GCCs) for leading global enterprises. &nbsp;&nbsp;&nbsp;</p><p>ANSR MedTech center brings together world-class engineering, product, and technology talent to build next-generation healthcare&nbsp;platforms and&nbsp;solutions that power global operations. &nbsp;&nbsp; &nbsp;</p><p><strong>Our Vision:</strong></p><p><strong>To build a next-generation MedTech capability center that powers global healthcare innovation. We envision: &nbsp;&nbsp;&nbsp;</strong></p><ul><li>High-impact innovation hubs shaping global product and technology roadmaps.</li><li>Centers that go beyond support functions to drive core engineering and platform development. &nbsp;</li><li>Sustainable, scalable ecosystems that nurture world-class MedTech talent.</li><li>Capability centers that directly influence patient outcomes worldwide.</li></ul><p>At its core, the ANSR MedTech Capability Center is about enabling innovation that touches lives at scale.&nbsp;</p><p><strong>About R&amp;D:</strong></p><p>The <strong>R&amp;D organization at ANSR MedTech</strong> is being built to support <strong>the development, testing, and long-term sustainment of complex, regulated products used at global scale.</strong></p><p>This team plays a critical role in <strong>engineering excellence, product quality, and operational reliability,</strong> working closely with global R&amp;D leaders to deliver against well-defined technical standards, quality systems, and product outcomes.</p><p>Unlike a traditional offshore or support model, R&amp;D in India is designed to take on <strong>meaningful ownership</strong> <strong>across the product lifecycle</strong>, particularly in areas where scale, focus, and execution discipline are essential.</p><p><strong>What Makes This Opportunity Stand Out:</strong></p><ul><li>Work on <strong>real, production</strong> <strong>grade products</strong> that require high engineering rigor, reliability, and regulatory discipline.</li><li>Be part of a team that spans <strong>embedded software, mobile applications, systems engineering, test automation, and lifecycle engineering.</strong></li><li>Contribute to end-to-end<strong> R&amp;D workflows</strong>—from development and verification through sustaining engineering and triage.</li><li>Help build and scale a <strong>new R&amp;D capability from the ground up</strong>, shaping labs, automation, ways of working, and quality culture.</li><li>Partner directly with <strong>senior global R&amp;D leaders and engineers</strong>, gaining exposure to how products are built and operated at enterprise scale.</li></ul><p><strong>How the R&amp;D Team Operates:</strong></p><ul><li>Teams are <strong>based in India and embedded in day-to-day delivery</strong>, not isolated support functions.</li><li>Technical direction, quality standards, and product outcomes are <strong>globally aligned</strong>, with strong local execution and accountability.</li><li>The organization is built under a <strong>Build–Operate–Transfer (BOT) model with ANSR</strong>, with responsibilities expanding as the site matures.</li></ul><p>Success is measured by <strong>engineering quality, predictable delivery, adherence to quality systems, reduced defects over time, and strong collaboration with global R&amp;D teams.</strong></p>","syndication_control":true,"syndication_status":"in_progress","syndication_job_title_alias":"[]","sourcing_requirements_updated_at":null,"t500_sourcing_control":true,"status":"open","job_redirection_url":null,"is_external_job":false,"is_leadership_job":false,"leadership_confidentiality_level":null,"pricing_type":null,"recruiter":"1154daea-f24c-4f7f-aad6-494543ee6112","category":13,"job_sub_category":8,"role":null,"job_function":921,"job_sub_function":1649,"naukri_industry":null,"naukri_functional_area":null,"naukri_role":null,"role_category":584,"linkedin_industry":null,"syndication_partners":["42df20d5-42f7-4c82-88fc-1bf5ce994984"],"candidate_job_status":null,"candidate_job_id":null,"mettl_assessment_to_be_taken":false,"company_font_data":{"font-family":"Montserrat","url":"https://fonts.googleapis.com/css2?family=Montserrat:ital,wght@0,100;0,200;0,300;0,400;0,500;0,600;0,700;0,800;0,900;1,100;1,200;1,300;1,400;1,500;1,600;1,700;1,800;1,900&display=swap"}}