Website:
mycareernet.in
Job details:
Key Skills: Regulatory Compliance, Embedded System, Risk Management
Roles and Responsibilities:
- 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
Skills Required:
- 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.
Education: Bachelor's or Master's degree in software engineering, computer science, electrical engineering, or related field
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