Senior Device Software Engineer - Macclesfield

CK Group
31 May 2018
17 Jun 2018
Contract Type
Full Time
Natasha Young at CK Group is recruiting for a Senior Device Software Engineer to work with a pharmaceutical company at their manufacturing operations site based in Macclesfield. This is a contract opportunity to join a company with a broad range of human healthcare products for an initial duration of 12 months.

The Senior Device Software Engineer will 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. The 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.

The Senior Device Software Engineer's responsibilities will include:
· Provide device expert support and guidance to projects
· 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.
· Be proactive in proposing new ideas and solving problems.
· Develop and maintain a level of knowledge and competence in device software development approaches and technologies.
· May represent the specialist area on Pharmaceutical Project Teams, ensuring the provision of appropriate data (technical, resource & budgetary).
· Assess and report data with a clear understanding of its reliability, interpret findings and draw authoritative conclusions and recommendations. Establish and maintain a close working relationship with development partners and suppliers and contribute to management of external collaborations
· Maintain a network of contacts across Pharmaceutical Technology and Development and other key groups. Contribute to the internal networks in the Device/Medical Device area
· May supervise staff and contribute to the training and development of new team members by acting as coach/mentor as appropriate

As Senior Device Software Engineer should have the following skills and experience:
· A background of 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
· Awareness of the global regulatory landscape for electronic/software-based medical devices
· Advantageous to have experience of preparing regulatory documentation e.g. in eCTD format.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference TC42154 in all correspondence.

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