Description

You will lead the architecture, design, and implementation of embedded software for In Vitro Diagnostic (IVD) medical devices.

Responsibilities

• Lead the design and implementation of embedded software and applications for IVD medical devices.
• Oversee maintenance of on-market product codebases, including bug fixing, performance improvements, and product updates.
• Ensure all development and maintenance activities adhere to regulatory standards including IEC 62304, ISO 13485, and FDA 21 CFR Part 820.
• Develop and execute unit and integration tests to meet performance and safety requirements.
• Conduct code reviews and mentor junior engineers to promote development best practices.
• Collaborate with hardware engineers, clinical scientists, and regulatory experts to meet clinical and technical needs.

Required Skills

• 6+ years of software development experience, with at least 4 years in medical devices or a regulated industry.
• Proficiency in C, C++, and Python.
• Experience with embedded systems, real-time operating systems (RTOS), and microcontrollers.
• Ability to independently set up and maintain development environments for ARM products and IAR embedded workbench.
• Knowledge of IEC 62304, ISO 14971, FDA 21 CFR Part 820, and FDA cybersecurity guidance.
• Experience with medical device software development lifecycles, design controls, risk management, and V&V activities.
• Experience with Agile/Scrum methodologies and Jira.
• Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related field.

Key Skills

Education

Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related field