Senior Systems Engineer

Job Description

As a Senior Systems Engineer you will provide advanced systems engineering contributions to the design and development of medical device systems. The role supports system-level architecture, requirements development, and lifecycle execution, ensuring customer, regulatory, and business needs are translated into robust, compliant designs. Works independently on complex assignments while collaborating closely with cross-functional teams and senior technical leaders.

**++Key Responsibilities++**

•Contribute to the definition and implementation of system architectures for new products and 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 to mechanical, electrical, and software teams.

•Execute system development activities across the product lifecycle, including concept development, requirements definition, design support, verification and validation, and design transfer to manufacturing.

•Develop, review, and maintain system-level documentation such as development plans, architectures, requirements, traceability matrices, specifications, test plans, protocols, reports, and technical analyses in accordance with design control requirements.

•Provide technical guidance and informal mentorship to engineers and technicians, supporting cross-functional problem solving and alignment.

•Support system-level testing, failure investigations, and technical assessments, contributing to evaluations of reliability, manufacturability, serviceability, and risk.

•Interface with suppliers, external partners, and test laboratories to support design reviews, testing activities, technical issue resolution, and design transfer readiness.

**++Education and Experience Requirements++**

•Bachelor's degree in Engineering or equivalent technical discipline, or an equivalent combination of education and experience.

•Minimum of 8 years of progressively responsible engineering experience in product and/or systems development, including exposure to system-level design responsibilities.

**++Role and Competencies Requirements++**

•Ability to work independently on complex system development tasks with moderate oversight and guidance from senior engineers or technical leaders.

•Working knowledge of FDA, ISO, and QSR requirements applicable to medical device development and design controls.

•Experience contributing to electro-mechanical system architectures and managing requirements through verification and validation.

•Working knowledge of root cause investigation, risk management, change management, and technical documentation.

•Effective written and verbal communication skills, with the ability to collaborate and influence cross-functional teams and external partners.

•Working knowledge of engineering test methods, including basic statistical concepts used in development and verification.

•Ability to travel domestically and internationally up to approximately 20% as required.