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Position Overview

As System Verification and Validation (V&V) Sr.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 leading/supporting all activities related to Design Verification of the medical devices. Candidate will also will be responsible in maintaining Lab equipment, work with Design engineers to help build Test fixtures/assemblies and assisting with overall Lab logistics.

Essential Duties and Responsibilities

Lead/Execute, perform, summarize, and report out System 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 Design Verification activites
Drive/Perform Installation/Operational/Performance Qualification Protocols
Prepare Traceability Matrices and Final Reports.
Lead compliance/ closure of Regulatory and Quality requirements
Develop 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.
Plan Lab logistics and maintain the material supply for testing requirements.
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 6 to 10 yrs of experience with minimum 3 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.

Preferred Candidates

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

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.

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Sr Eng, System Verification