Embedded Software Engineer

About the role

• The Embedded Software Engineer is responsible for coordinating software development activities including concept, development, verification, validation and sustaining software engineering source code and technical documentation. Programming and project management, coordinates internal and external teams

What you'll do

• 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.
• Make recommendations for software and hardware selection and improvements.
• Support the design transfer to manufacturing processes associated with embedded software and systems integration.

Qualifications

• Bachelor’s degree in Computer Science, Computer Engineering, Electrical Engineering, Biomedical Engineering. Master’s degree is a plus.
• 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.
• 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).
• 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.
• Quality Management System complaint to ISO 13485 and FDA 21 CFR Part 820.