Senior Device Software Engineer

Proclinical is working with a global pharmaceutical & Medical Device company based in the north west who are looking for a software quality engineer to join their dynamic team.
We are looking for an Engineer 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. The scope is primarily Mobile Medical Applications but may also include other connected devices.

Job 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).
• Prepare contributions to regulatory documentation.

Skills and Requirements:

• Degree and/or post-graduate qualification in a relevant subject
• Several 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.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Joseph Emmott on +44 203 8141 316 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.