Staff Engineer, Product Transfer

The Staff Engineer, Product Transfer is responsible for transferring product software from R&D into manufacturing, service, and cloud production environments. This includes creating validated system images, ensuring compliant installations, managing software patching, and partnering with third-party vendors to ensure successful software deployment and maintenance in production. The role ensures that all software release and transfer activities meet regulatory, cybersecurity, and quality system standards (FDA, ISO 13485, IEC 62304). In this hands-on role, you will collaborate closely with our Software, Hardware, Research, Quality and Regulatory and Operations teams-as well as other cross-functional partners-to transfer the product software to manufacturing. You will partner with Cepheid IDC and Cepheid Sunnyvale leadership to build technical capability at Cepheid.

This position is part of the R&D Department and will be located in Bangalore, IDC, India . Our vision is to continuously drive innovation and efficiency in our development processes, leveraging the latest in software and hardware technologies to meet the needs of our global customers.

In this role, you will have the opportunity to:

• Execute software design transfer from R&D to manufacturing for PCR diagnostic instruments and embedded systems, ensuring compliance with FDA and ISO standards
• Develop, validate, and deploy gold images and installation packages for Windows-based medical devices, servers, and embedded platforms used in production and field environments
• Define and document installation procedures and deployment protocols, including image creation, validation, and configuration of Microsoft OS, security patches, and approved third-party components
• Coordinate cloud-based deployment of medical software applications with validated cybersecurity controls, uptime monitoring, and data integrity safeguards
• Generate and maintain traceable design transfer documentation including build records, IQ/OQ/PQ validation summaries, and manufacturing instructions for regulated software releases

The essential requirements of the job include:

• Minimum 5 years of experience in software development, release engineering, or product transfer within a regulated medical device environment, including a bachelor's or master's degree in software engineering, computer science, electrical engineering, or related field
• Proficiency in medical device software lifecycle standards (IEC 62304), quality systems (ISO 13485), and familiarity with FDA 21 CFR Part 820
• Hands-on experience with system imaging tools such as Macrium, Clonezilla, MDT, or Acronis, and deployment on cloud platforms including AWS, Azure, or private cloud
• Practical experience with CI/CD pipelines, Git-based version control, and build automation tools
• Applied knowledge of software validation, risk management per ISO 14971, and cybersecurity standards including FDA cybersecurity guidance

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

• A background in leveraging AI to improve operational performance.
• Experience working with distributed teams in a global setting.
• Comfortable in using a wide variety of open-source technologies and tools.
• Experience with systems administration and IT operations (networks, cyber security, etc.)
• Experience with regulated environments - tool validation and validated processes.

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.

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