Senior Systems Engineer

As a Senior Systems Engineer you will provide advanced systems engineering contributions to the design and development of medical device systems. The role supports systemlevel 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 crossfunctional 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 flowdown 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 systemlevel 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 crossfunctional problem solving and alignment.
Support systemlevel 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

Bachelors 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 systemlevel 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 electromechanical 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 crossfunctional 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.