Eng II, System Verification
Baxter International Inc. · Bengaluru, Karnataka, India
- On site
- Full-time
- $100,000 / year
- Bengaluru, Karnataka, India
Job highlights
- Execute medical device verification tests.
- Develop test cases and procedures.
- Perform functional and performance testing.
- Analyze data and report findings.
- Ensure regulatory compliance.
About the role
Position Overview
As a System Verification Test engineer for the Infusion pumps team within the Medication Delivery business, the incumbent will have independent responsibility for clearly executing test procedures to support all activities related to the Design Verification of medical devices. The candidate will also assist in maintaining lab equipment, work with design engineers to help build test fixtures/assemblies, and assist with lab logistics.
Essential Duties and Responsibilities
- Lead/Execute, perform, summarize, and report out verification test activities for Medical devices, including understanding URS (User Requirements) / System Requirements, preparing System Level Test cases, and preparing test procedures.
- Understand product functionality and perform Functional and Performance testing for the product.
- Lead/Support and perform all Design Verification activities.
- 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, and 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 material supply for testing requirements. Support Calibration activities.
- Diagnose, isolate, and investigate problem reports and defects.
- Support working with external test houses (such as EMI, EMC tests for electrical boards and full devices) to define test scope, author test plans, test procedures, execute, and consolidate reports.
- Ensure good documentation and Good Manufacturing Practices are followed in the Verification Process.
- Experience in IEC basic safety, EMI-EMC standards.
- Interacts with the design team to resolve tests-related technical issues.
- Presents findings / objective evidence and is able to present with rationale, 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 a related field.
- Overall 5 to 8 years of experience with a minimum of 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 methods used to verify products in the realms of mechanical, electrical, and 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.
Key skills/competency
- System Verification Test
- Medical Device Testing
- Design Verification and Validation (V&V)
- Functional and Performance Testing
- Test Procedure Development
- Traceability Matrices
- IEC Standards (Basic Safety, EMI-EMC)
- Minitab, JIRA, ALM
- Regulatory Compliance (FDA, ISO, IEC)
- Electro-mechanical Testing
Skills & topics
- System Verification Engineer
- Medical Device Testing
- Design Verification
- Validation
- Test Engineering
- Infusion Pumps
- Electro-mechanical
- Regulatory Compliance
- FDA
- ISO
- IEC
- Minitab
- JIRA
- ALM
- Performance Testing
- Functional Testing
- Electrical Engineering
- Mechanical Engineering
- Quality Assurance
How to get hired
- Tailor your resume: Highlight system verification, medical device testing, and V&V experience.
- Showcase technical skills: Emphasize experience with Minitab, JIRA, ALM, and IEC standards.
- Demonstrate understanding: Reference FDA, ISO, and IEC design control procedures in your application.
- Highlight problem-solving: Detail your experience diagnosing and isolating defects in medical devices.
- Prepare for V&V questions: Be ready to discuss your experience with design verification and validation.
Technical preparation
Study medical device verification standards.,Practice designing test cases and procedures.,Review electro-mechanical and electrical testing concepts.,Familiarize with Minitab, JIRA, and ALM.
Behavioral questions
Describe a complex defect you diagnosed.,How do you ensure clear documentation?,How do you handle following instructions precisely?,Describe a time you worked with external teams.
Frequently asked questions
- What specific medical devices does the System Verification Engineer II role at Baxter International focus on?
- The System Verification Engineer II role at Baxter International specifically focuses on infusion pumps within the Medication Delivery business unit. This involves in-depth testing and verification of these critical medical devices.
- What are the primary responsibilities of a System Verification Test Engineer at Baxter International?
- Primary responsibilities include executing, summarizing, and reporting on verification test activities for medical devices, developing test cases and procedures, performing functional and performance testing, and supporting design verification activities. This also involves maintaining lab equipment and assisting with logistics.
- What educational background is required for the System Verification Engineer II position at Baxter?
- A Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering, or a related field is required for this role at Baxter International.
- What kind of experience is Baxter International looking for in a System Verification Engineer II candidate?
- Baxter is seeking candidates with 5-8 years of overall experience, including at least 2 years in System Verification testing and performance testing. Hands-on experience with design verification/validation of medical products and electro-mechanical/electrical testing is essential.
- Are there specific software tools mentioned for the System Verification Engineer II role at Baxter?
- Yes, Baxter mentions experience with tools such as Minitab for data analysis, JIRA for defect tracking, and ALM for test environment management as beneficial for the System Verification Engineer II position.
- What regulatory standards are important for this System Verification Engineer II role at Baxter?
- A basic understanding of and adherence to FDA, MDD/MDR, ISO, and IEC design control procedures, regulations, and standards is important. Experience with IEC basic safety and EMI-EMC standards is also required.
- Does Baxter International offer remote work options for the System Verification Engineer II position?
- The job description implies an on-site role with responsibilities including lab equipment maintenance and working with design engineers. Specific remote work options are not explicitly mentioned, suggesting it is likely an on-site or hybrid position.
- How does Baxter International ensure a fair hiring process for System Verification Engineer II applicants?
- Baxter International is an equal opportunity employer and 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.