Engineer Testing System Testing

As System Verification and Validation (VV) Test engineer for Infusion pumps team within Medication delivery business the incumbent will have an independent responsibility of following instructions clearly in executing Test procedures for supporting all activities related to Design Verification of the medical devices. Candidate will also assist in maintaining Lab equipment work with Design engineers to help build Test fixtures/assemblies and assisting with Lab logistics.

Essential Duties and Responsibilities Execute perform summarize and report out verification test activities Medical devices: Which includes but not limited to:

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

Understand the product functionality and perform the Functional and Performance testing for the product.

Support and perform all Design Verification activites

Perform Installation/Operational/Performance Qualification Protocols

Prepare Traceability Matrices and Final Reports.

Support compliance/ closure of Regulatory and Quality requirements

Follow Test instructions and Test protocols.

Follow instructions clearly from Design engineers during Test execution.Support Design engineers in Test fixture creation building up tearing down Test equipment.

Support Lab logistics and maintain the material supply for testing requirements. Support Calibration activities.

Diagnose isolate and investigate problem reports and defects.

Support to work 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 consolidate the reports

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

Experience in IEC basic safety EMIEMC standards

Interacts with design team to resolve testsrelated technical issues.

Presents the findings / objective evidences 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.

Overall 4 to 7 yrs of experience with minimum 2 years in System Verification testing and performance testing. Hands on experience in overall final design verification/validation(VV) testing of medical products. Relevant technical testing/reliability experience in electromechanical 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 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 FDAMDD/MDR ISO and IEC design control procedures regulations and standards