Job Description Insight Global is seeking a Principal Systems Engineer for a Medical Device company located in Minneapolis. As a Systems Engineer, your primary role will involve the development of electro-mechanical systems, system architecture, and the accompanying documentation in accordance with established quality system procedures. You will collaborate with multi-disciplinary teams to fulfill product and project requirements, engaging with engineers from diverse companies and industries. DUTIES AND RESPONSIBILITIES: · Develop and establish internal requirement sets and assist customers in formulating user requirements when necessary. · Contribute to the formulation of the risk management plan and associated reports. · Aid in the creation, review, and documentation of risk analyses. · Assist in the development of a Hazard Analysis as needed. · Ensure that product verification and validation are conducted, maintaining traceability for all requirements. · Facilitate and coordinate interdisciplinary technical discussions within project teams. · Oversee the coordination and documentation of system-level analyses, which includes system modeling, algorithm development, simulations, and system architecture. · Act as the main technical point of contact for customers on various projects. · Take responsibility for the technical project scope and associated efforts. · Participate in initiatives aimed at identifying and implementing technology reuse. · Engage in technical design reviews throughout the product realization process. · Assist in assessing technical talent. · Identify technical training needs and tools for the systems engineering team. 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 A Bachelor's degree in Computer Science or an Engineering field. · A Master's degree in Engineering is an advantage. · At least five years of experience is required, preferably in the medical device industry, focusing on systems engineering. · Familiarity with system designs that adhere to IEC 60601, ISO 13485, ISO/EN 14971, and IEC 62304 standards is essential. · Experience with requirements management tools will be considered a plus. · Proficiency with modeling tools such as Matlab and Simulink is desirable. · Understanding of the FDA 510(k), PMA, and De Novo pre-market submission procedures is advantageous. · Experience in developing Class II and III medical devices is beneficial. 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.