Sr Eng, System Verification

• Lead/Execute, perform, summarize, and report out System verification test activities Medical devices
• 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

• 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

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

• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer