Director, Systems Engineering

Job Description Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Cepheid, 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. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world's most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible. We are seeking a highly influential and experienced Director of Systems Engineering to lead the technical conscience of our R&D organization. This critical leadership role owns the holistic technical vision and execution for our diagnostic platforms. You will be responsible for leading the teams that define, integrate, verify, and ensure the reliability of our complex products. You will lead our System Architects, System Integration Engineers, Verification & Validation (V&V) Engineers, and Reliability Engineers. Your primary mission is to ensure that we build the right product and that we build the product right, meeting all user needs, technical requirements, and stringent regulatory standards. This position reports to the Senior Director Systems Engineering and is part of the Research & Development department, located in Bengaluru, IDC, India, and will be based on-site. In this role, you will have the opportunity to: - Direct the systems engineering function across architecture, integration, verification, validation, and reliability, ensuring alignment with ISO 13485 and FDA QSR (21 CFR 820) standards - Oversee end-to-end requirements management, translating clinical workflows into technical specifications using tools such as IBM DOORS or Jama Connect - Lead system architecture development, including trade-off analysis and platform scalability decisions, with proficiency in model-based systems engineering (MBSE) frameworks - Manage integration of multidisciplinary subsystems-hardware, software, firmware, and biochemical assays-using structured integration plans and risk-based methodologies - Own the V&V strategy and execution, including authoring and approving test protocols and reports for regulatory submissions under FDA and CE marking requirements - Implement reliability engineering practices including FMEA, HALT/HASS, and predictive analytics to meet product lifetime targets and reduce field failure rates - Administer product risk management activities per ISO 14971, ensuring traceable mitigation strategies across the full product lifecycle using validated risk analysis tools The essential requirements of the job include: - Minimum 15 years of experience in software-driven electro-mechanical product development, including at least 7 years in a senior systems engineering leadership role, with a Bachelor's or Master's degree in Systems Engineering, Biomedical Engineering, or a related discipline - Demonstrated leadership of full systems engineering lifecycle using the V-model, including requirements definition, system architecture, integration, verification, and validation - Proven track record of launching at least three regulated medical or diagnostic products to market under FDA and international regulatory frameworks - Hands-on management of cross-functional engineering teams responsible for system architecture, integration, verification and validation (V&V), and reliability engineering - Expert-level proficiency in applying ISO 13485, FDA 21 CFR Part 820 (QSR), and ISO 14971 to product development and risk management processes - Experience with product development and documentation tools such as DOORS, Polarion, or equivalent requirements management systems It would be a plus if you also possess previous experience in: - Minimum 10 years of direct experience in the Class II or Class III medical device or in-vitro diagnostics (IVD) industry - Expertise in using requirements management and ALM tools (e.g., Jama Connect, DOORS, Codebeamer) - Experience with Human Factors and Usability Engineering (IEC 62366) - Formal training in Systems Engineering (e.g., INCOSE CSEP) - Exceptional ability to influence cross-functional partners and to communicate complex technical concepts to all levels of the organization 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 .