Systems Engineer - Joule : Job Details

Title: Systems EngineerLocation: Onsite- Philadelphia, PASchedule: M-F 9:00 am-5:00 pmType: Direct-Hire/PermanentStart: ImmediatelyOverview:The Systems Engineer (SE) will be responsible for managing and tracking the User needs and be responsible for translating them into Design Input Requirements for the diverse systems comprising our client's technology. Defining the acceptance criteria, strategizing, driving the validation of the device will be other tactical responsibilities of the SE. The SE will also be responsible for the Gas control systems of our client's offerings.Responsibilities Mange stakeholder needs and consolidate the currently identified needs from diverse documents into a foundational view to support ongoing product development.Manage the Design Input Requirements from diverse documents, identify and fill the gaps maintain proper traceability.Manage a Risk analysis based engineering process incorporating Hazard analysis, failure modes, effects and correction analysis process that is consistent with the regulatory guidelines.Be responsible for cross disciplinary interfaces (eg electrical, mechanical, and software) and drive optimal designs.Produce documentation to support regulatory submissions (reports and requirement traces)Develop the cross functional acceptance criteria for the features of the device and be responsible for product validation prior to clinical trials.Lead Design Reviews for requirement updates and design approvals.Manage the gas control sub-system including mass flow controllers and gas supply.Requirements: Engineering degree in any related discipline – Biomedical, Mechanical, Electrical or Software5+ years' experience as a hands-on contributor in any of the related disciplines – mechanical, electrical, software or control systems.3+ years as a systems engineer in Medical Device engineeringDemonstrated track record in establishing, following FMECA techniques, Hazard AnalysisHospital based therapeutic device experience required. ECMO devices and/or Hemodynamic support devices preferred.Ability to select, integrate sensors, OTS devices, activators for specific functions into the product using a formal deliberate process.#M3