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Design Verification Engineer - Waukesha, United States - Brooksource
Description
Primary Purpose:
I am actively seeking a Verification Engineer to join my Global Medical Technology Client. The ideal candidate will play a pivotal role in ensuring the quality and compliance of their premium suite of medical device products. Your primary responsibility will be to conduct manual hands-on testing, focusing on design verification and compliance with regulatory standards, particularly those set forth by the FDA.
Major Responsibilities:
Design Verification: Confirm design outputs for the CT product suite to ensure alignment with design requirements. This involves meticulous testing procedures and adherence to established processes.
Compliance: Ensure compliance with regulatory standards, particularly FDA regulations governing medical device testing and certification.
Test Process Development: Develop and refine testing processes to improve efficiency and effectiveness. Collaborate with engineering teams to establish robust testing protocols.
Test Case Development: Assist in the development of test cases while ensuring they align with design specifications. Take ownership of defining necessary tasks and ensuring comprehensive coverage.
System-Level Testing: Conduct testing at the system level to evaluate the performance and functionality of the entire CT system. This includes formal user interface testing, image quality testing, calibrations, and verifications.
Verification Cycles: Participate in multiple verification cycles throughout the year, from preparation to execution. Continuously learn from previous cycles to enhance testing methodologies and develop tests for upcoming cycles.
Engineering Activities: Collaborate with engineers to enhance test procedures and optimize performance. This may include activities such as image reconstructions and working on formal user interfaces.
Ownership: Independently take ownership of tasks and demonstrate accountability in resolving issues and improving processes.
Logical Thinking: Clear and logical thinking to interpret test results and understand the underlying intent of tests.
Knowledge, Skills & Abilities Required:
Bachelor's degree in Engineering, Computer Science, or related field.
Experience in verification and validation testing, preferably in the medical device industry.
Familiarity with FDA compliance standards and regulations.
Prior experience in manual testing procedures, particularly in a medical device testing environment.
Whats In It For You?
Highly competitive compensation
Medical/Dental/Vision plans, matching 401(k)
Holiday PTO
Professional Training Opportunities
Excellent Work/Life Balance
About Brooksource
Brooksource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.
