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.

· 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.

• 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!!!