Senior Systems Engineer

Nextern•Maple Grove, MN

22d•$95,000 - $155,000

About The Position

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.

Requirements

A Bachelor's degree in Computer Science or an Engineering field.
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.

Nice To Haves

A Master's degree in Engineering is an advantage.
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.

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.