For this search, we are seeking a seasoned Systems Engineer to help lead the overall systems development for new electronic chest drainage devices.
Chest drains are used following open or thoracic surgery and chest trauma to evacuate any air and/or fluid. The current “typical” chest drain is a non-electronic, gravity based, analog medical device.
These new electronic chest drains provide increased functionality and improved patient diagnostic information for the clinical team.
To succeed in this role, you will have a strong System Engineering background and acumen; this position will require the application of your Software (Firmware / IEC 62304); Electrical (PCBAs / Circuit Design); Mechanical (molded parts / pneumatics), and general medical device systems (IEC 60601 / ISO 13485) experience.
You will be challenged by designing complex parts/assemblies with embedded control systems; managing the overall design and creation of the Firmware and PCBAs (including the selection of ICs, memory, power and electrical specifications); troubleshootingelectrical/software defects; and ensuring all of this is completed per project schedule.
As an experienced medical device System Engineer, you will be comfortable with creating and releasing the applicable documentation and specifications in support of this device (e.g. HW/SW requirements, code reviews, FMECAs, Risk Management, Test Methods / Specifications /Reports, Verification, and Validation).
The ideal candidate would have a minimum of twelve years’ experience in the development of electronic medical device systems that connect into a Hospital Information System.
Req Id 15162.