Sr. Systems Engineer
The Sr. 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.
THIS ROLE REQUIRES FDA-REGULATED MEDICAL DEVICE EXPERIENCE. OTHERS WILL NOT BE CONSIDRED!
Leads system design requirements analysis, integration, test (verification), and 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.
Creates and maintains traceability documents for multiple projects and products using appropriate tools.
Ensures compliance to applicable standards.
Interfaces with customer facing team to capture product requirements and helps capture them into system requirement specifications.
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.
Performs hands-on system verification and validation testing, puts together detailed test report, and communicates and helps triage technical issues.
Creates procedures and reports, performs and analyzes system set up, and conducts verification and validation activities.
Develops test plans and test protocols; performs troubleshooting, diagnoses and resolves problems to component, module, and system level, with the R&D team
Acts as focal point of technical contact for system level complex issues related to performance, stability, and quality.
Ensures compliance to organizational processes, 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 development process.
SKILLS AND KNOWLEDGE:
B.S. or M.S. degree in Mechanical, Electrical, Computer or Systems Engineering.
Experience with development in a FDA-regulated industry for medical device.
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.
Proven record of successfully delivering system design achieving product launch and shipment.