Senior Software Engineer
Job Summary My client is a global healthcare organisation based in the North West that is currently recruiting for a senior software engineer to support the development of several new software devices. This role requires project management skills, a thorough understanding of software development and design control procedures, and close working with other functions, external suppliers and consultants. Purpose of the role The main purpose of the role will be to Lead and support design and development of device software products (Medical Device software, Software as a Medical Device and connected devices), ensuring work meets internal and external Design Control requirements.
Job Overview Roles and Responsibilities
• Provide device expert support and guidance to projects within AZ’s Intelligent Pharmaceuticals group developing device software products.
• Manage device software aspects of development projects or support elements of complex projects to achieve project targets in a timely fashion and to agreed quality standards. Plan and review work to ensure that agreed objectives, timescales and budgets are met.
• Lead specific device development activities e.g. Risk Assessments, Design Reviews.
• Prepare device documentation ensuring its compliance with internal and external quality and regulatory requirements (e.g. QSR/ISO/MDD/GMP/GLP and SHE requirements).
Skills Required • Degree and/or post-graduate qualification in a relevant subject
• A number of years’ experience working within a regulated software development lifecycle, ideally in a pharmaceutical or med-tech environment.
• Understanding and application of Agile software development methodology – ideally in a medical device context
• Knowledge and experience of working with electronic/software-based medical device processes e.g. medical device quality management systems, design controls, risk management, software validation and human factors.
• Demonstrated experience of working within device design control procedures and knowledge of associated tools such as risk analysis.
• In depth knowledge and application of international device standards that relate to electronic/software-based medical devices (ISO 14971, IEC 62304, ISO 13485, IEC 60601 etc.) and other relevant regulations and guidelines
Contact Details Full job description and company details are available upon application, apply below. This position is being dealt with by Matt Lowe-Lauri at meet, call on +44 (0) 2030195988 or email directly at firstname.lastname@example.org to discuss in confidence.