Senior Engineer- V&V

Our client is an American multinational healthcare company. For over a century now, they have delivered on their commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world. At the intersection of progress and purpose, they are redefining what it means to be a global medtech leader. Their forward-looking leadership team is a driving force in ensuring we meet the needs of all our stakeholders—every day and everywhere. They strive to create lasting value by empowering their patients, protecting the planet, and championing people and communities.

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.

Requirements:

• 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.