Our client, a leading manufacturing company in it's field, is seeking a talented Lead Software Engineer to join their team.

Position overview

In this role, you will initially focus on hands-on code writing and development, with the potential to progress into management and leadership of a software development team. You will be responsible for creating software for regulated medical devices in an ISO 13485 regulated environment. This includes ensuring adherence to relevant medical device standards, such as ISO62304, and producing documentation, records, and code commentary for design history files.

The Lead Software Engineer should have significant experience in creating code and algorithms using MATLAB, C/C++, and Python, with a preference for embedded software development. Understanding of systems and control theory, and the ability to create algorithms for hardware control, would be advantageous. Additionally, you will work closely with the Engineering team to collect and process data from data loggers and instrumentation for testing and debugging purposes.

Key responsibilities

• Understand technical and user requirements
• Create and document software for the company's future product pipeline
• Follow relevant medical device standards (e.g., ISO13485, ISO62304, ISO14971) in software creation and documentation
• Write efficient, logical, and well-commented code
• Perform verification and validation of code through testing
• Potentially manage the software development team
• Create software for data collection, processing, and other purposes
• Maintain up-to-date software documentation for the Quality Management System
• Interface software with hardware, such as UI code
• Collaborate on IP development and strategy with the SLT

Qualifications and experience

• Experience creating software for life science applications
• MATLAB, C/C++, or Python
• Writing embedded code (preferred)
• Extensive experience in writing software compliant with medical device regulations and standards
• Managing a team of people (preferred)
• Setting up and maintaining a Quality Management System for software
• Conducting software risk assessments
• Designing systems and control algorithms (preferred)
• Experience with electromechanical and/or fluid systems and hardware

Our client offers a competitive salary, along with share options and a generous holiday allowance. If you are a skilled Lead Software Engineer with a background in regulated medical devices, this is an exciting opportunity to join a pioneering company on the brink of revolutionising it's field.

Please reach out for more details.