Software Engineer II

The Software Engineer II is responsible for ensuring that medical diagnostic systems meet design specifications and regulatory requirements through rigorous testing and documentation. This role involves planning, executing, and reporting on verification and validation activities to guarantee product quality and compliance.

This position reports to the Engineering Manager and is part of the Instrument RD located in Bengaluru and will be an on-site role.

In this role, you will have the opportunity to:

• Develop and execute test plans, protocols, and reports for software and system-level verification and validation.
• Perform functional, integration, and regression testing of medical device software.
• Collaborate with cross-functional teams to identify test requirements and ensure traceability to design inputs.
• Utilize automated and manual testing techniques to validate system performance and reliability.
• Document test results and maintain compliance with regulatory standards (ISO, FDA).

The essential requirements of the job include:

• Bachelor s degree in Engineering, Computer Science, or related field. 5+ years of experience in software/system verification and validation, preferably in a regulated environment.
• Strong knowledge of QA methodologies, QMS, and hands-on experience with whitebox and blackbox testing.
• Familiar with testing client/server applications, Team Foundation Server (TFS), and Agile development practices.
• Strong knowledge of testing methodologies, tools, and best practices.
• Familiarity with risk management and requirements traceability.
• Ability to work independently and in a collaborative team environment.
• Expert in Manual Testing Automated Testing
• Expert in Python language and ability to build automation solutions using appropriate frameworks.
• Experience in Agile development processes and philosophies.
• History of timely delivery while ensuring a quality focus.
• Ability to work well with people and be both highly motivated and motivating
• Ability to work in a fast-paced, and often ambiguous environment where continuous improvement is a way of life
• Ability to work independently and proactively with minimal direction.

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

• Experience in medical device Verification Validation documentation is a plus
• Experience in IVD instrumentation, such as clinical chemistry, immunoassay, hematology, urinalysis, molecular, microbiology or flow cytometry systems is a plus
• Understanding of software development processes and verification and validations for a regulated environment (ISO9000/FDA) is a plus
• Experience in verification frameworks and build management is a plus
• Experience in Python frameworks is a plus