Garner, NC, 27529, USA
2 days ago
Systems V&V Engineer, R&D
Job Description We are seeking a Systems Verification & Validation Engineer, R&D with a strong background in the medical device industry to join our engineering team. This role will be responsible for leading the verification and validation (V&V) efforts for electro-mechanical medical devices, ensuring compliance with regulatory standards, and collaborating across multiple functions to deliver high-quality products. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements 3-5 years of experience in medical device verification and validation within a regulated industry. Direct experience with Systems V&V for complex electro-mechanical medical devices. Familiarity with industry standards, specifically ISO 13485 Proficiency in test methodology, automation, and data analysis. Proven ability to write and execute system-level V&V protocols and review requirements. · Experience with X-Ray or other radiological medical devices.  · Familiarity with developing test tools and methods for system verification.  · Knowledge of IEC 60601-1 and testing for hardware-firmware-software interface designs.  · Experience with requirement management tools such as JAMA or DOORS. - Proficiency in Python or MATLAB for test automation and data analysis. null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
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