- Diploma or bachelor's degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field

- 5 to 10 yrs. of experience in System Verification testing System functionality and performance.

- Relevant technical testing/reliability experience in electro-mechanical, electrical testing of Medical Devices.

- An understanding of test methods and processes as well as the methods used to verify product in the realms of; mechanical, electrical, functional, and environmental testing environments.

- Basic hands-on experience in data analysis of Performance testing and Sample size calculations for variable/Attribute data

- Experience in Tools like Minitab (Data Analysis) / JIRA ( Defect) / ALM ( test Environment) etc.

- Understanding of hardware and software product design methodologies and test practices.

- Experience in medical device or similar product development, design verification/validation, system integration (hardware/Subsystem/Software), risk management, reliability engineering, process validation, and Quality systems

- Basic understanding of and adherence to FDA, MDD/MDR, ISO, and IEC design control procedures, regulations, and standards.

- Self-motivated with good interpersonal skills.

- Ability to follow instructions clearly.

Roles and Responsibilities :

- Execute, perform, summarize, report out verification test activities of components to a full system device: Which includes but not limited to:

- Understand URS (User requirements) / System Requirements and prepare the System Level Test cases and Prepare test procedures.

- Perform the Functional and Performance testing for the product.

- Support and perform Design Verification activities.

- Perform Installation/Operational/Performance

Qualification Protocols :

- Prepare Traceability Matrices and Final Reports.

- Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables.

- Follow Test instructions and Test protocols.

- Follow instructions clearly from Design engineers during Test execution.

- Support Design engineers in Test fixture creation, building up, and tearing down Test equipment.

- Support Lab logistics and Support Calibration activities.

- Diagnose, isolate and investigate problem reports and defects.

- Works with external test houses (such as EMI, EMC tests for electrical boards, and full device) to define the test scope, author the test plans, test procedures, execute and consolidate the reports

- Ensure good documentation and Good Manufacturing practices are followed in the Verification Process

- Experience in IEC basic safety, EMI-EMC standards

- Interacts with the design team to resolve test-related technical issues.

- Presents the findings/objective evidence and able to present with rationale with applicability/exclusions

- Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed.

- Tools Microsoft office, Minitab( Data Analysis) / JIRA ( Defect ) / ALM ( test environment)

Qualification :

- Diploma or bachelor's degree in Mechanical engineering, Electrical Engineering/ Electronics, Bio-Medical, Industrial Engineering or related field

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