EMED Technologies Corporation is looking for an Embedded Software Engineer to coordinate software development activities for medical drug delivery devices, ensuring compliance with industry standards and regulations.
Requirements
- Experience using tools such as code review applications, software configuration management, Unified Modified Language (UML), C++, Qt, QML, J2EE .Net technologies, platforms that helps teams develop, secure, and deploy software for designing and development of medical devices embedded software systems.
- Experience with medical software and risk management standards such as IEC 62304 and ISO 14971.
- Experience in developing / coordinating development of embedded software for system on chip (SoC) hardware and real time operating system (RTOS).
- Quality Management System complaint to ISO 13485 and FDA 21 CFR Part 820.
Responsibilities
- Coordinate development and approvals of specifications and implementation of embedded software for medical drug delivery devices following IEC 62304, software hazards analysis and cyber security risk management controls per ISO/IEC 14971, FDA regulations and global medical industry standards.
- Understands the end user perspective and requirements, accurately converts that into software designs inputs to establish topologies, software design requirements and architecture documentation, plans for software and system features to satisfy product design requirements and system components.
- Project manage internal and external team members for software development and, when necessary, multidisciplinary team members,
- Works with Systems, Electronic & Mechanical engineers, quality and regulatory professionals.
- Able to use software engineering tools and techniques such as continuous integration, static code analysis, test automation and code generation.
- Coordinate the design and implementation of code verification testing plans and procedures for software verification testing and Human Factors Engineering Validation.
- Support the design transfer to manufacturing processes associated with embedded software and systems integration.
Other
- 8+ years of experience in software development for medical devices, or three years of progressive experience in software development in lieu of every year of education.
- Project management skills to lead projects and team members, internally and externally, organizing, and prioritizing workflow to meet schedules.
- Responsible, able to work independently without supervision and as a team player.
- Good communication and presentation skills.
