Senior Systems Engineer

7 days ago

Maple Grove, Minnesota, United States Nextern Full time $95,000 - $155,000 per year

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

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