Engineer II, Verification & Validation

Role overview

Engineer II, Verification & Validation at Baxter

Responsibilities

• Support compliance/ closure of Regulatory and Quality requirements Follow Test instructions and Test protocols.
• Support 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.

Required qualifications

• What you’ll bring 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.

Employment details

• Location: Bengaluru [Karnataka] [India]

Application details

• 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 link here and let us know the nature of your request along with your contact information.
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About the employer

• At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life.
• Your Role at Baxter As System Verification 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.
• 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.

Benefits

• We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
• What you’ll be doing 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.
• Hands on experience in overall final design verification/validation(V&V) testing of medical products.
• 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.

Additional role details

• This is where your work makes a difference.
• It was our founding belief in 1931 and continues to be our guiding principle.
• Our Baxter colleagues are united by our Mission to Save and Sustain Lives.
• Together, our community is driven by a culture of courage, trust, and collaboration.
• Every individual is empowered to take ownership and make a meaningful impact.
• We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
• Here, you will find more than just a job—you will find purpose and pride.
• Candidate will also assist in maintaining Lab equipment, work with Design engineers to help build Test fixtures/assemblies and assisting with Lab logistics.
• Understand the product functionality and perform the Functional and Performance testing for the product.
• Lead/Support and perform all Design Verification activates Perform Installation/Operational/Performance Qualification Protocols Prepare Traceability Matrices and Final Reports.
• Follow instructions clearly from Design engineers during Test execution.
• Support Design engineers in Test fixture creation, building up & tearing down Test equipment.
• Support Calibration activities.
• 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.
• 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.
• Self-motivated with good interpersonal skills.
• Ability to follow instructions clearly.
• Equal Employment Opportunity Baxter is an equal opportunity employer.
• Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.