Sr. Systems Engineer
Role details
Job location
Tech stack
Job description
The Systems Engineer will support Medical Device Systems, with a focus on Clinician Instruments and External Stimulators. This role is a seasoned individual contributor position, responsible for system integration, verification, and validation activities across the product lifecycle. The engineer will work independently under limited supervision and collaborate closely with cross-functional partners to ensure system performance, quality, and regulatory compliance.
Primary Day-to-Day Responsibilities
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Develop System Tests - Create system-level verification and validation test plans, protocols, and procedures based on product and system requirements.
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Execute Tests - Perform hands-on system testing to verify functional, performance, and safety requirements.
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Identify and Analyze Issues - Investigate failed tests, identify root causes, document defects, and collaborate with engineering teams to drive resolution.
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Perform technical planning, system integration, verification, and validation activities for complex medical device systems.
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Analyze system performance at all levels of product development, including concept, design, fabrication, test, installation, operation, maintenance, and disposal.
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Ensure the logical and systematic conversion of product requirements into system solutions, considering technical, schedule, and cost constraints.
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Conduct functional analysis, timeline analysis, trade studies, requirements allocation, and interface definition to translate customer requirements into hardware and software specifications.
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Evaluate design alternatives, including cost, risk, and supportability, and provide recommendations to improve system performance and reliability.
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Support cross-functional teams (R&D, quality, manufacturing, and regulatory) during system development and issue resolution.
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Document test results, defects, and system performance data in accordance with regulatory and quality standards.
Requirements
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Technical Degree - Bachelor's degree in Electrical Engineering (EE), Mechanical Engineering (ME), Software Engineering (SW), or a closely related field., * System Integration Experience - Ability to integrate complex hardware-software systems and ensure seamless functionality across system components.
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System Verification Experience - Strong background in developing and executing verification and validation tests.
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5-10 years of relevant systems engineering experience, preferably in medical devices or regulated industries.
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Strong experience with system-level testing, verification, and validation.
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Familiarity with requirements management, defect tracking, and test documentation.
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Working knowledge of project management principles is a plus.