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Tier-1 brand, metro Bengaluru location, and mid-level candidate profile increase competition.
Medical-device V&V and regulatory standards demand industry-specific experience, reducing cross-industry transferability.
Explicit 2+ years plus regulated documentation and protocol execution make screening moderately strict.
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Own verification and validation activities for Immunoassay and Clinical chemistry product lines including instrument maintenance and test protocol development/execution.
Create and execute verification and validation test plans to support new product development and hardware/software design delivery.
Collaborate with global R&D team to identify, analyze, and resolve system-level defects with root cause analysis.
Bachelor’s or Master’s degree in Science, Engineering, or related field.
2+ years of relevant experience.
Experience executing test protocols in laboratory settings.
Ability to work on-site at India Development Center, Bengaluru.
Familiarity with middleware, ASTM/HL7 communication protocols, and regulated documentation practices.
Experience or knowledge in medical devices, biotech, or FDA-regulated environments is a plus.
Understanding of medical device quality standards like IEC 62304, ISO 13485, ISO 14971, or software testing qualifications such as ISTQB foundation.