Staff Systems Engineer

The Staff Systems Engineer provides advanced technical leadership and hands‑on systems engineering support for the design and development of complex medical device systems. This role contributes to system‑level architecture definition, translates customer and regulatory requirements into executable designs, and supports system development activities from concept through design transfer. The position operates with moderate autonomy, influencing technical decisions through strong systems expertise and effective cross‑functional collaboration.

Key Responsibilities

• Contribute to the definition, development, and refinement of system architectures for new products and significant product enhancements, ensuring alignment with customer needs, regulatory requirements, and business objectives.
• Translate user, customer, and business needs into clear, testable system and subsystem requirements, and support effective flow‑down of requirements to mechanical, electrical, and software teams.
• Support and execute system development activities across the product lifecycle, including concept development, requirements definition, design, verification and validation, and design transfer to manufacturing.
• Develop, review, and maintain system‑level documentation, including development plans, architectures, requirements, traceability matrices, specifications, test plans, protocols, reports, and technical analyses, in accordance with design control processes.
• Provide technical guidance and informal mentorship to engineers and technicians, coordinating across disciplines and contributing to technical direction under the guidance of senior technical or project leadership.
• Support system‑level testing, failure investigations, and technical assessments, evaluating reliability, manufacturability, serviceability, and risk throughout development
• Act as a technical contributor and interface to suppliers, external partners, and test laboratories, supporting design reviews, testing execution, issue resolution, and design transfer readiness.

Education and Experience

• Bachelor’s degree in Engineering or a related technical discipline, or an equivalent combination of education and experience.
• Minimum 10+ years of progressively responsible engineering experience in product and/or systems development, including exposure to system‑level design, integration, or verification activities.

Role and Competencies Requirements

• Demonstrated ability to contribute effectively to complex, multi‑disciplinary system development efforts with defined objectives and moderate oversight.
• Working knowledge of FDA, ISO, and QSR requirements applicable to medical device development and design controls.
• Experience supporting electro‑mechanical system architectures and managing requirements through verification and validation.
• Proficiency in root cause investigation, risk management, change management, and technical documentation.
• Effective written and verbal communication skills, with the ability to collaborate with cross‑functional teams, suppliers, and external partners.
• Working knowledge of engineering test methods and basic project management principles, including statistical concepts used in development and verification.
• Ability to travel domestically and internationally up to approximately 20% as required.