The Senior Systems Verification Engineer I for Beckman Coulter Diagnostics is responsible for designing, developing, troubleshooting Electro-Mechanical / Opto-Electrical System modules for laboratory medical device new product development. The incumbent practices best design practices and follow quality processes defined during development.

This position reports to the Head of Life Cycle Management & Group Manager and is part of the R&D Hardware/Systems Development team located in Bengaluru BDC and will be an on-site role.

In this role, you will have the opportunity to:

Author, review, and execute system-level test protocols to validate design changes.
Ensure test coverage for accuracy, performance, throughput, carryover, and linearity Etc. requirements.
Analyze test data and generate statistically sound reports to support design verification and release decisions.
Evaluate whether design changes meet existing system specifications/requirements and performance benchmarks and changes do not compromise product integrity or clinical outcomes.
Participate in DFMEA reviews, identifying and testing for potential failure modes. Perform DFMEA test protocols to validate mitigations and assess risk impact.
Develop and execute reliability test protocols, including accelerated life testing and environmental stress testing. Perform statistical analysis of reliability and performance data using tools such as Minitab, JMP, or Python/R. Interpret results to estimate product life, failure rates (MTBF = Mean Time Between Failures), and confidence intervals.

The essential requirements of the job include:

Bachelor s or Master s degree in Biomedical engineering, Electrical Engineering, Systems Engineering, or related field.
3+ years of experience in medical device V&V, preferably in diagnostics or imaging systems.
Strong understanding of design control, risk management, and reliability engineering.
Proficiency in statistical analysis and tools for data interpretation.
Familiarity with DFMEA, ISO 14971, IEC 60601, and FDA QSR.
Experience in setting up experiments using external sensors and data acquisition systems such as LabVIEW, NI DAQ, or similar platforms.
Experience with requirement management tools (e.g., IBM DOORS, Jama) is a plus.
Familiarity with regulatory and safety standards (IEC 62304, ISO 13485, FDA Class II).

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

Experience in medical device design & development is a plus
Experience in IVD instrumentation, such as clinical chemistry, immunoassay, hematology, urinalysis, molecular, microbiology or flow cytometry systems is a plus
Familiarity with lean manufacturing and Six Sigma principles

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Senior Systems Verification Engineer I