Director Product and Digital Quality

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences,diagnosticsand biotechnology

At Cepheid, one of15+ operating companies, our work saves lives-andwe'reall united by a shared commitment to innovate for tangible impact.

You'llthrive 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'llget 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 thewhich makes everything possible.

The Director Product and Digital Quality is accountable for ensuring design quality, regulatory compliance, and innovation excellence across a complex, globally integrated product development ecosystem. This role provides direct ownership of System Design Controls, Software Validation, NonProduct Software Quality, Process Controls, Product & Information Security, and AI Strategy. The position also provides administrative oversight for Regulatory Affairs associates responsible for Class II global registrations. The Director will work closely with cross-functional teams including R&D, Regulatory Affairs, Operations, Clinical Affairs, Product Security, and Corporate Quality to deliver safe, effective, compliant Class II devices aligned with global medical device standards.

This position is part of theQualitydepartmentand willbe located in the India Development Center, Bengaluru, India.The Quality department collaborates with cross-functional business partners to ensure that customer needs and safety aremet,government regulations and quality requirements are effectivelymonitored, measured,maintainedand continuously improved.

In this role, you will have the opportunity to:

• Lead endtoend System Design Controls for Class II devices, ensuring clear user needs, robust design inputs/outputs, traceability, risk management, and V&V aligned with regulatory expectations
• Oversee Software Validation (product and nonproduct) including embedded software, mobile apps, cloud components, and support systems used for development and quality system operations.
• Champion Innovation Quality frameworks, ensuring risk-based decision-making and enabling early design-stage quality alignment to accelerate compliant innovation and reduce time-to-market.
• Drive Product & Information Security compliance, ensuring cybersecurity-by-design for connected and software-enabled devices per FDA, MDR, and global cybersecurity frameworks.
• Lead AI/ML Quality and Risk Governance software applications, ensuring safe, compliant, and ethical implementation of machine learning components in accordance with evolving global regulations.
• Lead and develop associates, including providing performance reviews, coaching, succession planning, resource allocation, competency development, and fostering a highperformance culture across the matrix organization
• Provide administrative oversight of Regulatory Affairs associates, ensuring alignment with registration strategies, technical documentation needs, and post-market regulatory requirements

The essential requirements of the job include:

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Electronics, or related field. Master's degree (M.Tech, MS, MBA) preferred.
• 16+ years in the Medical Device industry or related industry, with significant experience specific to Class II devices, including design controls, product development quality, and regulatory collaboration.
• 8+ years of proven experience leading multi-disciplinary teams within a matrix organization skilled in influencing cross functional teams and developing emerging leaders
• Deep knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 82304, ISO-27001, ISO 42001, FDA 21 CFR Part 820, and cybersecurity frameworks relevant to Class II devices.
• Excellent communication, cross-functional leadership, executive presentation skills, and ability to manage complex global stakeholders.

It would be a plus if you also possess previous experience in:

• Experience in Agile scrum software development methodology
• Experience with applications such as complaint tracking, automated testing applications, web-based applications, requirements management systems are a plus.
• Experience with software lifecycle processes, AI governance, cloud/mobile device development, and digital QMS tools.

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whetherit'sa health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at.

This job is also eligible for bonus/incentive pay.

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 .