Staff Engineer - Product Transfer

MyCareernet; Bengaluru; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

A medical technology company seeks an experienced professional to execute software design transfer for PCR diagnostic instruments, ensuring FDA and ISO compliance. Candidates must have a minimum of 5 years in software development within a regulated environment, with a Bachelor's or Master's in a related field. Familiarity with system imaging tools and cloud platforms like AWS and Azure is essential. This role offers the opportunity to innovate in medical technology and contribute to critical software lifecycle activities.

Qualifications

• Minimum 5 years of experience in software development within a regulated medical device environment.
• Proficiency in software lifecycle standards (IEC 62304) and quality systems (ISO 13485).
• Hands-on experience with system imaging tools and cloud-based deployments.

Responsibilities

• Execute software design transfer from R&D to manufacturing for PCR diagnostic instruments.
• Develop, validate, and deploy gold images and installation packages for medical devices.
• Coordinate the deployment of medical software applications with cybersecurity controls.

Skills

Regulatory Compliance

Embedded System

Risk Management

Software Development

Release Engineering

Education

Bachelor's or Master's degree in software engineering, computer science, electrical engineering, or related field

Tools

Macrium

Clonezilla

MDT

Acronis

AWS

Azure

Job description

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