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 ownership across the product lifecycle, particularly in areas where scale, focus, and execution discipline are essential.
What Makes This Opportunity Stand Out:
- Work on real, production grade 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:
The Sr. Manager, Systems Engineering will provide leadership through motivation, guidance, and open communication enabling the team's growth and success. They will manage a team of systems, software development and test engineers, balance technical expertise and leadership while ensuring technical risk reduction in engineering programs. Sr. Manager, Systems Engineering will oversee post-market activities, including field investigations, CAPA execution, and obsolescence planning; they will drive continuous improvement to support product development and lifecycle management for in-market and near-market products.
Responsibilities:
- Attract, develop and retain the best talent to ensure the highest standard of excellence in systems engineering resulting in the delivery of high-quality innovations to patients globally.
- Manage the development of hardware and software enabled systems, those that interact with human or machines, and functional activities relevant to achieving these goals. This includes driving functional excellence in identifying, breaking down and solving technical problems associated with design and development of system architectures, testing, product and other system engineering aspects.
- Champion best-in-class systems engineering methodologies, optimizing workflows and efficiency.
- Oversee root cause investigations, risk evaluations, and design change assessments ensuring seamless transition of information from the field to development and vice versa.
- Drive post-market initiatives, including field investigations, CAPAs, failure and risk analysis, health-hazard analysis and obsolescence planning.
- Ensure traceability among design input, design output, verification/validation, and risk management artifacts to maintain a complete design history file within QMS compliance.
- Collaborate cross-functionally including but not limited to Customer Support, Product Support, R&D SW development, Product Management, Regulatory, Quality, DevOps.
- Drive continuous improvement initiatives, refining systems engineering processes for better quality, compliance, and adherence to ALM and PLM frameworks.
Leadership & Interpersonal Skills:
- Proven ability to motivate and mentor engineers in a highly regulated environment.
- Skilled in cross-functional collaboration, coordinating with leadership, technical experts, and external partners.
- Strong decision-making skills, balancing technical challenges with business objectives.
- Excellent communicator, able to engage stakeholders at all levels of an organization.
Education and Experience:
- Bachelor of Science or higher in System Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related field.
- Minimum of 10 years of overall experience in systems engineering, lifecycle engineering, sustaining, R&D, or related technical roles in medical devices or other regulated industries.
- At least 4 years of people management experience, preferably with multi-disciplinary teams.
Demonstrated experience in:
- Documentation requiring traceability and regulatory review.
- Requirements, V&V, Risk Analysis, Issue Management, Change management, and Root Cause Investigation Methods.
- CAPA execution, failure analysis, and post-market regulatory compliance.
Preferred Skills and Competencies:
- Graduate Degree (MSc, PhD) in Engineering or Management.
- Conflict resolution expertise, ensuring coordination across teams.
- Excellent verbal and writing skills that enable communication to different levels.
- Organizational awareness and ability to garner support with a bias towards action.
- Proficiency in Lifecycle tools (e.g. Polarion ALM, Helix ALM).
- Six Sigma training or certification.
- Authoring design inputs, V&V plans, protocols, and reports in compliance with ISO 13485, ISO 14971, IEC 60601, IEC 62304, and FDA 21 CFR Part 820.30
Physical Requirements:
- Must be able to sit or stand for 8 hours a day.
