Position Overview:
As System Verification and Validation (V&V) 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, EMI-EMC standards
Interacts with design team to resolve tests-related 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.
Qualifications / Experience and/or Background
Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
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(V&V) testing of medical products.
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 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
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