Senior Embedded Software Engineer
Development of electromechanical Medical Devices for a growing medical device startup.
Overview:
Drive patient-focused products from prototype to market by leading the design of device firmware.
Responsibilities: Working with Design, Quality, Marketing and Clinical stakeholders to define and document firmware/software requirements.Collaborate with electronic hardware design colleagues to identify suitable electronic components to meet design requirements.Write, test, and refine firmware to meet design requirements.
Demonstrate compliance with requirements through extensive design testing.Preparing and reviewing test protocols for design verification and compliance testing (e.g.
IEC 60601 series, IEC 62304).Problem solving test failures or product issues in the field and providing software solutions to prevent these issues.Preparing design documentation to ensure compliance with relevant standards, such as IEC 62304.Identifying areas of potential improvement through automation.Writing code to automate testing processes successfully.Lead software validations to ensure we can use data gathered from automated test cycles.Creating and managing a software development lifecycles process, compliant with IEC 62304 and ISO 13485.Work with our front-end innovation team to create early stage device, service, and software application prototypes for solution demonstrations with key opinion leaders, patients, and customers. Requirements: Completed at least 3 significant software/firmware design projects from the definition of requirements through to production release.4 years of electronics and firmware design experience, ideally in a medical device or similarly regulated environment.Prior experience of writing documentation to support your software/firmware design.Experience with software tools for static and dynamic analysis, memory management, code coverage, and techniques for analysing software.Experience of completing software validations per IEC 62304 and its application to Software Development Life Cycle.Familiarity with communication protocols like UART, SPI, I2C.Experience working to general quality standards such as ISO 13485.A qualification in Software Engineering, Computer Science, Electronic Engineering, Mechatronic Engineering or similar.
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