ANSR is hiring for one of its clients.
About ANSR MedTech:
Who We Are:
ANSR MedTech Capability Center is a new global innovation hub being established in India for a Fortune 100 Fastest-Growing Company in the 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.
ANSR MedTech center brings together world-class engineering, product, and technology talent to build next-generation healthcare platforms and solutions that power global operations.
Our Vision:
To build a next-generation MedTech capability center that powers global healthcare innovation. We envision:
- High-impact innovation hubs shaping global product and technology roadmaps.
- Centers that go beyond support functions to drive core engineering and platform development.
- Sustainable, scalable ecosystems that nurture world-class MedTech talent.
- Capability centers that directly influence patient outcomes worldwide.
At its core, the ANSR MedTech Capability Center is about enabling innovation that touches lives at scale.
About R&D:
The R&D organization at ANSR MedTech is being built to support the development, testing, and long-term sustainment of complex, regulated products used at global scale.
This team plays a critical role in engineering excellence, product quality, and operational reliability, working closely with global R&D leaders to deliver against well-defined technical standards, quality systems, and product outcomes.
Unlike a traditional offshore or support model, R&D in India is designed to take on meaningful ownershipacross the product lifecycle, particularly in areas where scale, focus, and execution discipline are essential.
What Makes This Opportunity Stand Out:
- Work on real, productiongrade products that require high engineering rigor, reliability, and regulatory discipline.
- Be part of a team that spans embedded software, mobile applications, systems engineering, test automation, and lifecycle engineering.
- Contribute to end-to-end R&D workflows—from development and verification through sustaining engineering and triage.
- Help build and scale a new R&D capability from the ground up, shaping labs, automation, ways of working, and quality culture.
- Partner directly with senior global R&D leaders and engineers, gaining exposure to how products are built and operated at enterprise scale.
How the R&D Team Operates:
- Teams are based in India and embedded in day-to-day delivery, not isolated support functions.
- Technical direction, quality standards, and product outcomes are globally aligned, with strong local execution and accountability.
- The organization is built under a Build–Operate–Transfer (BOT) model with ANSR, with responsibilities expanding as the site matures.
Success is measured by engineering quality, predictable delivery, adherence to quality systems, reduced defects over time, and strong collaboration with global R&D teams.
Position Overview:
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.
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.
This position will report to the Manager, Systems Design Verification at Bengaluru, India.
Responsibilities:
- Manage all Verification and Validation activities and deliverables for New Product Development and sustaining products in accordance with Client's Quality Management System and applicable medical-device regulations and standards.
- Provide technical leadership for System Design Verification team.
- Lead initiatives to advance processes and tools related to Design Verification activities according to System Engineering COE department objectives
- Leads the development and execution of system integration, system verification and regression plan.
- Develop, review, implement and maintain test strategies, test protocols, test cases, test reports and traceability matrices for system verification.
- Report defects found during testing and assist in root cause analysis.
- Drive the impact analysis and effort estimates
- Collaborate with Systems Engineering to ensure that requirements are testable and appropriately leveled for verification with component level test teams (Hardware/Software)
- Co-ordinate with project managers, system engineers and other technical leads to plan and execute project goals
- Participate in regular cross-site stand-ups with the Acton site System Test engineers 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).
- Coordinate task assignment and prioritization with the Acton site System Test engineer and Release Leads; execute assigned verification test tasks, track progress, raise blockers early, and provide timely status updates and deliverables.
- Work closely with System Automation Test team to optimize test coverage and test execution strategy
- Define, track and report KPIs for product verification and product quality
- Mentor to junior team members on topics such as sample size justification, statistical analysis, risk-based test coverage optimization
- Manage and track product configurations including hardware, software, firmware version tracking and determine the impact due to configuration changes for System Design Verification
Education and Experience:
Minimum Requirements:
- Bachelor's degree in Biomedical Engineering, Software Engineering, Computer Science or an engineering related field.
- 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
- Experience working in an Agile based Software Development environment
- Good written and verbal communication skills including cross functional communication experience
- Experience working with requirements management tool (Helix, Jama, and/or Polarion), quality management system, test case management tool, defect management tool is preferred
Preferred Skills and Competencies:
- Test Engineering training and/or certification is a plus.
- Strong technical judgement with extensive technical leadership skills.
- Demonstrated capability of leading System design verification for programs on an electromechanical device.
- Excellent Program Management Skills – PMP Certification a plus.
- Experience guiding team/individuals to develop technical solutions to complex problems.
- Sound knowledge of engineering first principals.
- Strong Analytical and Problem-Solving Skills.
- Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
- Demonstrated skills developing and introducing innovative FDA-regulated medical devices (Class 2 or 3) under Design Controls.
- Experience with design and development processes that conform to standards such as ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
Physical Requirements (if applicable):
- Must be able to sit or stand for periods of time.
- The person will need to be on site in the Bengaluru office at least 3x/week; may work remotely other days.
