Systems Engineer
OVERVIEW:
The Systems Engineer will apply in-depth knowledge of systems engineering principles, concepts, and techniques across various disciplines through the translation of user needs into a system design that achieves those needs, as well as through support of system integration activities.
The role provides technical guidance to cross functional teams and directs system-level mechanical, electrical, software and other product-specific requirements. The role is also instrumental in risk assessment/management, product verification, regulatory, and certification activities.
Only candidates from medical/medical device manufacturing companies will be considered!
RESPONSIBILITIES:
Leads system design requirements analysis, integration and test (verification), validation for medical device system, subsystem or system elements.
Recognizes architectural patterns, applies them appropriately, understands strengths/weaknesses within those architectures and develops architectural variations as necessary.
Provides support in the inception, design & execution of complex engineering projects over the full life cycle of product development.
Provides engineering support to projects during their test and launch phases.
Provides systems engineering services for sustainment of Company products and supports development of new systems and capabilities.
Acts as project manager responsible for cost, schedule, and technical performance, as assigned.
Performs hands-on system integration testing and troubleshooting of technical issues.
Creates procedures and reports, performs and analyzes system set up, and conducts verification and validation activities.
Develops test plans and test protocols; perform troubleshooting, diagnoses and resolves problems to component, module, and system level.
Ensures compliance to organizational policies, procedures, and quality requirements in an FDA-regulated environment.
Produces high quality documents and written reports, describing test-related topics in a clear and concise style and in full accordance with the organizational processes.
SKILLS AND KNOWLEDGE:
Only candidates from medical/medical device manufacturing companies will be considered!
Degree in Mechanical, Electrical, Computer or Systems Engineering.
Experience with development in a regulated industry such as medical device, defense.
Experience in Systems Engineering as related to functional architecture and system design.
Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans and reports.
Risk management (risk analysis) experience strongly desired.
Ability to work on multiple projects in a deadline driven environment.
Ability to provide creativity while solving complex problems.
Strong track record of technical leadership and working in cross-functional teams.