System Verification Engineer II

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