The Systems Verification Validation Engineer is responsible for all the verification and validation activities for the Immunoassay and Clinical chemistry product lines. This includes instrument maintenance, drafting and execution of verification and validation test protocols, and working with the broader RD team to support verification and validation activities.
This position reports to the Engineering Manager Systems Verification Validation and is part of the Global Systems RD Team located in India Development Center, Bengaluru and will be an on-site role.
In this role, you will have the opportunity to:
- Create verification and validation test plans in support of new product development and continuous delivery of hardware and software design.
- Write and execute verification and validation test protocols following approved procedures and documentation standards.
- Identify, analyze and drive resolution of system level defects with strong root cause analysis.
- Work with the broader global RD team to support verification and validation activities.
The essential requirements of the job include:
- Bachelor s or Master s degree and 2+ years of experience in Science, Engineering or related field.
- Ability to execute test protocols in a laboratory setting.
- Exposure to middleware, ASTM/HL7 communication protocols.
- Robust attention to detail and understanding of regulated documentation practices.
It would be a plus if you also possess previous experience in:
- Medical devices, Biotech, or FDA regulated environments.
- ISTQB foundation in Software Testing or equivalent competence to undertake the qualification.
- Experience of medical device quality standards such as IEC 62304, ISO 13485 and ISO 14971
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.