Senior Systems Engineer

The Sr. Systems Engineer's 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. · Contribute to the identification and protection of Nextern's intellectual property. 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. Benefits Compensation: The expected salary for this position is between $95,000-$155,000 annually, depending on experience, skills, qualifications. Health Care Plan (Medical, Dental & Vision) Retirement Plan with Company Match Paid Time Off, Personal Days, AND Birthday Holiday! Lifetime Membership Subsidy and Wellness Resources Life Insurance (Basic, Voluntary & AD&D) Family Leave (Maternity, Paternity) Short-Term & Long-Term Disability Taco Thursdays!!!