Job Title: Systems Engineer

Job Description

We are seeking a Systems Engineer responsible for developing electro-mechanical systems and system architecture, along with associated documentation per established quality procedures. This individual will lead multidisciplinary teams to meet product and project requirements, collaborating with engineers from various companies and industries. In addition to systems engineering duties, this individual will serve as the Hardware Engineer on the project team and act as the technical liaison for the customer.

Responsibilities

• Serve as the primary technical contact for customers on projects.
• Coordinate and facilitate interdisciplinary technical discussions within project teams.
• Accountable for the technical project scope and effort.
• Lead hardware engineering efforts on the project team.
• Coordinate and document system-level analysis including system modeling, algorithm development, simulations, and system architecture.
• Create and build internal requirement sets and assist the customer in developing user requirements when needed.
• Support the development of risk management plans and reports.
• Ensure product verification and validation, and ensure traceability is met for all requirements.
• Perform and participate in technical design reviews during product realization.

Essential Skills

• Bachelor's degree in Electrical Engineering or Computer Engineering.
• Five or more years of experience, preferably in the medical device field, in systems engineering.
• Five or more years developing electronic hardware in regulated environments with system designs compliant with IEC, ISO/EN, and IEC standards.
• Substantial experience in Hardware Development prior to transitioning into a systems role.

Additional Skills & Qualifications

• Master’s Degree in Engineering is a plus.
• Experience with requirements management tools is a plus.
• Experience with modeling tools such as Matlab and Simulink is a plus.
• Knowledge of FDA 510(k), PMA, and De Novo pre-market submission processes is a plus.
• Experience developing Class II and III medical devices is a plus.