We are looking for individuals who have a strong background in systems engineering and are passionate about system maturity/reliability, integration, characterization, verification, and validation. The ideal candidate would be someone with relevant educational and/or demonstrated experience maturing complex systems with significant electrical components.
- Work with peer systems engineer(s) during development of user needs & intended uses and design input requirements to ensure they are validate-able and verifiable respectively.
- Authors a system level Verification & Validation Plan, documenting scope of system V&V effort, while working with product/functional engineers to ensure proper and complete coverage.
- Authors Integration Plan and corresponding test protocols during design development phase of project to progressively and predictably build design maturity. Executes tests per defined Integration Plan.
- Works with various stakeholders to understand scope of characterization needed, including need to understand design capability. Executes system characterization efforts.
- Influence product/component integration and characterization plans in order to assist in incremental system maturity. Works with engineers in various functional departments to achieve results.
- Authors design verification and design validation protocols and reports. Executes system verification and validation activities.
- Works with Human Factors engineer to ensure inclusion, tracing and proper coverage of applicable user needs in their summative usability study.
- Works with Clinical to ensure inclusion, tracing and proper coverage of applicable intended uses in their pre-clinical or clinical study.
- Plan and execute Test Method and Non-product software validation, and equipment and tooling qualification, per project needs.
- Monitors progress of assigned tasks to defined project schedule.
- Produce high quality deliverables while complying with relevant SOP.
- Authors Summary report and other relevant inputs for submission by Regulatory Affairs to regulatory agencies in support of market release review and approval.
- Bachelor's Degree is required, Electrical Engineering or Systems Engineering preferred
- Experience within a highly regulated environment
- Strong background involving systems level testing
- Excellent communicator
If you are interested in learning more about this opportunity please apply at the details below.
Sthree US is acting as an Employment Business in relation to this vacancy.