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88694 EEssential Duties and Responsibilities

Lead/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.

Lead/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 5 to 8 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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Preferred Candidates

System V&V Engineers with Experience in Infusion pumps design verification testing.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

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