Lead Systems Engineer

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.  You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the which makes everything possible. The Lead Systems Engineer for Beckman Coulter Diagnostics is responsible for designing, developing, troubleshooting Electro-Mechanical / Opto-Electrical System modules, applying life cycle management principles and upholding established design practices and quality processes throughout development. This position reports to the Head of Life Cycle Management & Group Manager and is part of the R&D Hardware/Systems Development team located in Bengaluru – BDC and will be an on-site role.  In this role, you will have the opportunity to: Lead system architecture design for complex diagnostic medical devices with embedded hardware/software subsystems, define system requirements, interface specifications, and ensure traceability throughout the design lifecycle. Drive system-level risk management activities including DFMEA, fault tree analysis, and safety assessments. Lead system integration, verification, and validation in compliance with IEC 60601, ISO 13485, and FDA guidelines. Coordinate with stakeholders from engineering, regulatory, clinical, and QA teams to ensure product success. Own system-level documentation and lead design reviews, design controls, and regulatory submissions, Mentor junior engineers and contribute to continuous improvement of systems engineering processes. Define and manage performance accuracy and linearity requirements across subsystems. Conduct MATLAB-based analysis and validation of system models and test results. Assess design changes for system-level impact and manage corresponding documentation to support manufacturing teams with end-of-life (EOL) planning and ongoing sustainment activities. The essential requirements of the job include: B.E./B. Tech and M.E./M. Tech in Systems, Electrical, Biomedical, Mechatronics or Electronics Engineering. 7-10 years of experience in systems engineering within the medical device or diagnostics industry. Experience with regulatory compliance and standards such as IEC 60601, ISO 14971, ISO 13485 and CLSI guidelines. Proficient in system modeling tools (e.g., SysML, Minitab, Lab View) and requirement management platforms. Experience with requirement management tools (e.g., IBM DOORS, Jama). It would be a plus if you also possess previous experience in: Experience in medical device design & development and Deep understanding of systems engineering principles, lifecycle models (V-model, Agile), and risk management is a plus Experience in IVD instrumentation, such as clinical chemistry, immunoassay, hematology, urinalysis, molecular, microbiology or flow cytometry systems is a plus Familiarity with lean manufacturing and Six Sigma principles Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.