Sr. Systems Engineer

OVERVIEW:

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!

RESPONSIBILITIES:

  • 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.

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