Staff Systems Engineer

The Staff Systems Engineer provides advanced technical leadership and handson systems engineering support for the design and development of complex medical device systems. This role contributes to systemlevel 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 crossfunctional 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 flowdown 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 systemlevel 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 systemlevel 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

• Bachelors 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 systemlevel design integration or verification activities.

Role and Competencies Requirements

• Demonstrated ability to contribute effectively to complex multidisciplinary 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 electromechanical 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 crossfunctional 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.