Senior Embedded Software Engineer, Medical Devices (Regulatory)

TransMedics, Inc.; Andover (MN); On-site; USD 129,000 - 184,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K Plan

Employee Stock Purchase Plan

Job summary

TransMedics, Inc. is seeking a Senior Software Development Engineer to contribute to the full life cycle of embedded software that preserves donated organs for the Organ Care System.

The role partners with stakeholders to define requirements, implement and unit test embedded code, and ensure regulatory alignment with FDA guidance and IEC 62304. The ideal candidate has 8+ years of real-time embedded software experience in C/C++ (Qt a plus) and will drive verification, documentation, and field

Qualifications

• BS/MS in Software Engineering, Electrical Engineering, or equivalent combination of education and experience.
• 8+ years of real-time embedded software development experience.
• Proficient in C and C++; Qt framework is a plus.

Responsibilities

• 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 (FDA guidance, IEC 62304).
• Manage procedures and deliverables for software verification.
• Address field complaints by identifying root cause and implementing corrective actions.
• Support quality audits and FDA submissions.

Skills

C and C++

Qt framework

RTOS

GNU/Momentics

Education

BS/MS in Software Engineering or Electrical Engineering

Tools

ARM Processor

PIC microcontroller

JTAG

Git

JIRA

Job description

TransMedics, Inc. is seeking a Senior Software Development Engineer to contribute to the full life cycle of embedded software that preserves donated organs for the Organ Care System.

The role partners with stakeholders to define requirements, implement and unit test embedded code, and ensure regulatory alignment with FDA guidance and IEC 62304. The ideal candidate has 8+ years of real-time embedded software experience in C/C++ (Qt a plus) and will drive verification, documentation, and field