| QA Test Lead (Medical Devices & Embedded Experience) | Location: Chanhassen, MN at Chanhassen, Minnesota, USA |
| Email: [email protected] |
| From: David Johnson, concord it systems [email protected] Reply to: [email protected] Role: QA Test Lead (Medical Devices & Embedded Experience) Location: Chanhassen, MN SHOULD HAVE EXPERIENCE IN EMBEDDED MEDICAL DEVICE TESTING DAY 1 ONSITE Job Description: Conduct Product functionality analysis based on product requirements Executes, performs, summarizes, reports out verification & validation test activities of component / Sub-system Responsible for independently Planning, Verifying and Validating the device with minimal / no supervision Work closely with cross-functional teams in all aspects of device testing and test framework V&V work specification development, material testing, Functional testing Document Test Plans, Test Procedures based on functional and usability requirements Document Installation/Operational/Performance Qualification Protocols Participates in the development of Verification & Validation methodologies in accordance with applicable medical standards. Supports the qualification of verification lab, productivity improvement efforts, including testing, building fixtures, calibration and data collection. Hands-on with oscilloscope, function generator, DMM and other Lab measurement instruments Establish test, verification guidelines and framework required for verification Identifies the defect, reports and verifies in defect management tool following defined process. Ensures Implementation of the outcome from Verification /Validation into the system and ensures compliance. Prepares an MIS to the extent that Regulatory/Safety/RM Issues are covered Required Skill Sets: Experience in medical device or product development, design verification/validation, risk management, reliability engineering, process validation and Quality systems. Expertise in design and development of test Automation Frameworks. Experienced in system integration (involving software & hardware) and related verification Experience in Test Automation of Android or iOS devices using Appium. Experience in API testing using tools such as Rest Assured or similar. Experience with Unit Test Framework TestNG/ Junit, Cmock. Experience in working in Embedded development from at Hardware Prototype level Understanding or exposure to wireless protocols - Wi-Fi, Bluetooth Low Energy (BLE) Experience in Bus & Protocol Analyzer such as CATC USB Chief, Wireshark network packet analyser, I2C/SPI/UART with software or logic analyser Exposure to Device level Performance testing and Memory Analysis and Metrics identification An understanding of test methods and processes as well as the methods used to verify product in the context of software, mechanical, electrical, functional and environmental testing environments. Relevant technical testing/reliability experience in electro-mechanical, electrical testing. Demonstrated initiative and analytical thinking style, able to comprehend complex problems and good problem-solving skills Experience working with SCM tools like Git/ SVN. Experience in JIRA/Requirement management tool. Knowledge of IEC 60601-1-1, 1-2 standards FDA guidelines Thanks & Regards David Johnson Sr.IT Recruiter Desk Number: +1 209 706 0814 Concord Id :[email protected] Keywords: quality analyst information technology |
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| Mon Jan 09 21:05:00 UTC 2023 |