The role of Software Engineer is responsible for developing, testing, documenting, and maintaining software for medical devices and related systems. Building upon the company’s success in organ preservation for liver transplantation, several new applications of the technology are now being actively developed. The Software Engineer will be involved in the full lifecycle of new software development, as well as the maintenance of existing code. As a medical device company, software documentation and procedures adhere to the relevant standards under the guidance of the Director of Regulatory Affairs. The Software Engineer will join a rapidly growing engineering team and will have a proven track record in software development.
Under direction from the Software Development Manager the Software Engineer will:
1. Develop software through the full lifecycle process in accordance with software standards and procedures up to class C according to IEC 62304.
2. Complete relevant documentation, design verification plans and complete verification test reports for devices and systems, according to documentation procedures.
3. Contribute as part of the team to assist in other tasks as necessary.
Skills and Experience – Essential
‘ Good communication skills and written English.
‘ Ability to work effectively in a multi-disciplinary team.
‘ Have a proven track record of analytical problem-solving skills.
‘ Be able to demonstrate a methodical approach to programming and software testing.
‘ Experience in the design, development, implementation, and validation of software for medical or other risk compliant/regulated industries.
‘ Familiar with complying with standard operating procedures, coding standards, quality management system, etc.
‘ Working to strict timescales and being flexible to achieve.
‘ Real Time Operating Systems, ideally VxWorks and FreeRTOS.
‘ Embedded systems programming/debugging in C.
‘ Windows application programming in C#/.Net using Microsoft Visual Studio.
‘ Web application programming using ASP.NET, SignalR and Internet Information Server (IIS).
‘ SQL programming.
Skills and Experience – Desirable
‘ Familiarity with the regulatory requirements for medical software for compliance with European and United States quality standards, with practical working knowledge of IEC 62304, ISO 13485, and 21 CFR Part 11 quality systems.
‘ Ability to identify risks in software requirements and implementations and assess the severity and probability of occurrence.
‘ Safety critical software development.
‘ Systems design and unit test design.
‘ Knowledge of digital electronics, familiarity with software implementation using electronic component datasheets, using oscilloscopes, in-circuit debuggers, working closely with electronics engineers, etc.
‘ Microsoft Entity Framework.
‘ Unit testing in Microsoft Visual Studio.
‘ Development Tools: Cantata, WindRiver Work Bench, MPLAB X, IAR Embedded Workbench, mikroC PRO.
‘ Administration of Microsoft Windows Server, Microsoft Internet Information Server, and Microsoft SQL Server.
‘ Communication protocols, e.g., UDP and TCP/IP.
‘ Microsoft Office applications, ideally Office 365.
To apply, please send your CV to [email protected]