Our client, a leading Medical device startup, is hiring an Embedded Software Engineer to lead the development of device firmware across a portfolio of products.
Responsibilities include but are not limited to the following:
* 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.
* Lead automation of processes to help us bring state of the art products to patients by:
o Identifying areas of potential improvement through automation.
o Writing code to automate testing processes successfully.
o Leading software validations to ensure we can use data gathered from automated test cycles.
o Creating and managing a software development lifecycle process, compliant with IEC 62304 and ISO 13485.
* Work with the front-end innovation team to create early-stage device, service, and software application prototypes for solution demonstrations with key opinion leaders, patients, and customers.
* 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 in a medical device company.
* 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 analyzing 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.
Nice to Have:
* Experience working with wearable or home-use medical devices.
* Experience working with front-end software prototyping and design tools.
* Experience working with ARM microcontrollers.
* Experience working with RTOS (Real Time Operating Systems).
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