Senior Software Engineer will have the opportunity to contribute to the life cycle of embedded software applications for medical device development.

ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:

• Work with stakeholders to determine software requirements and develop risk analysis for new applications

• Design, implement, unit test, and document embedded software
• Write and execute software unit and system test plans and procedures

• Develop and maintain software development procedures per regulatory standards, e.g., FDA guidance, IEC 62304
• Manage procedures and deliverables for software verification

• Address field complaints by determining root cause and implementing corrective actions
• Support quality audits and the development of FDA submissions

REQUIREMENTS:

• BS/MS in Software Engineering, Electrical Engineering, or equivalent

• 8 years of related experience in real-time embedded software development in a Class II or Class III FDA regulated environment

• Very strong experience with C and C
• Device driver level development (e.g., UART, I2C, SPI, ADC, BT, USB OTG) preferred
• ARM Processor and PIC microcontroller development preferred
• Experience with RTOS (e.g., QNX RTOS or equivalent)
• Standard embedded development and debug tools (e.g., GNU, Momentics, JTAG)
• Standard Configuration Management and Project Tools (e.g., Git, JIRA, Scripts, Labview)
• Familiarity with CI/CD build environment infrastructure
• Integration of testing, static analysis, and security frameworks, a plus

• Must be team-oriented with outstanding interpersonal and communication skills (written and verbal)
• Must be detail oriented and highly organized