Job Description
The Sr. Embedded Software Engineer position is responsible for software development for Class II and III
medical devices. This position will lead embedded firmware development in the area of medical device
manufacturing and development of neuromodulation platforms and ASICS.
This position will develop code to operate active and passive implantable/external medical devices. This individual will work with a multi-disciplinary engineering team including software, electrical and mechanical hardware engineers, and all other functions of the company to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy face paced environment.
ESSENTIAL RESPONSIBILITIES
* Utilize UML tools, cross compilers, and version control tools to design and create embedded
firmware
* Create and review test software requirements
* Oversee and direct the work of contractors assigned to the project
* Assist in the mechanical and electrical design of devices
* Architect, develop and execute the firmware
* Develop user and system documentation
* Participate in produce development meetings and software/hardware design and risk analysis
reviews
* Specify and assemble development prototypes
* Ensure that medical device components are compliant with applicable international standards and
requirements
* Maintain software/hardware design history files and participate in periodic phase reviews
* Report defects to the stakeholders
* Provide inputs to the team in order to improve the medical device design
* Reliable, consistent, and punctual attendance is an essential function of the job.
* Complies with company, quality, and safety standards, policies, and procedures.
QUALIFICATIONS
* A Bachelor's Degree (STEM engineering discipline preferred) and 5 years of experience required; or a
combination of education and relevant work experience.
* Experience in an engineering environment with mechanical, tool design, and manufacturing
processes (medical device preferred).
* Working knowledge in electronics, analog, power and digital, oscilloscopes, and general electronic
test equipment.
* Working knowledge of implantable/external medical devices and their interfaces.
* Must be able to read, write and speak fluent English.
* Excellent oral, written, and presentation communication skills.
PREFERRED QUALIFICATIONS
* Experience in development of firmware for active implantable devices
* Experience with the medical device IQ, OQ, PQ test stand progression
* Familiarity with medical development standards such as IEC 60601-1, 62304,60601-1-2, ISO
14708-1, 14708-3
* SysML, UML and MBSE knowledge
* Knowledge of quality control principles and methodology