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!!!
Skills Required
- Bachelor's degree in Computer Science or Engineering
- Master's degree in Engineering (advantage)
- At least five years of experience in systems engineering
- Familiarity with IEC 60601, ISO 13485, ISO/EN 14971, and IEC 62304
- Experience with requirements management tools
- Proficiency with Matlab and Simulink
- Understanding of FDA 510(k), PMA, and De Novo procedures
- Experience in developing Class II and III medical devices
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
