Senior Embedded Software Engineer
Develop innovative electromechanical Medical Devices for a rapidly growing medical device company.
Key Responsibilities:
* Collaborate with cross-functional teams (Design, Quality, Marketing, and Clinical) to define and document firmware/software requirements.
* Work closely with electronic hardware design colleagues to identify suitable electronic components that meet design specifications.
* Write, test, and refine firmware to meet design requirements.
* Demonstrate compliance with requirements through extensive design testing.
* Prepare and review test protocols for design verification and compliance testing (e.g. IEC 60601 series, IEC 62304).
* Analyze and troubleshoot test failures or product issues in the field, providing software solutions to prevent these issues.
* Develop and maintain design documentation to ensure compliance with relevant standards (e.g. IEC 62304).
* Identify areas of potential improvement through automation.
* Write code to automate testing processes successfully.
* Lead software validations to ensure data gathered from automated test cycles is reliable.
* Create and manage a software development lifecycle process compliant with IEC 62304 and ISO 13485.
* Collaborate 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:
* At least 3 significant software/firmware design projects completed from definition to production release.
* 4+ years of electronics and firmware design experience, preferably in a medical device or similarly regulated environment.
* Prior experience writing documentation to support software/firmware design.
* Familiarity with software tools for static and dynamic analysis, memory management, code coverage, and techniques for analyzing software.
* Experience 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 degree in Software Engineering, Computer Science, Electronic Engineering, Mechatronic Engineering, or similar field.