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Title: Systems Engineer

Location: Onsite- Philadelphia, PA

Schedule: M-F 9:00 am-5:00 pm

Type: Direct-Hire/Permanent

Start: Immediately

Overview:

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 Software

• 5+ 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 engineering

• Demonstrated track record in establishing, following FMECA techniques, Hazard Analysis

• Hospital 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

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.