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.
Bonus or Equity
This position is also eligible for bonus as part of the total compensation package.
Pay Range
The salary range for this position (in local currency) is 109,700.00 - 183,200.00
