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AstraZeneca
,
Macclesfield, Cheshire
Associate Principal Scientist - Software Medical Devices
Overview
Job Description
AstraZeneca is a global, innovation-driven bio-pharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have an outstanding workplace culture that encourages innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energised and rewarded for their ideas and creativity. Lead and proactively provide experienced scientific contribution to the design and development and lifecycle management of device software products (Medical Device software, Software as a Medical Device and connected devices), ensuring work meets internal and external Design Control requirements and quality standards. The role requires strong device and software technical capabilities alongside project management and innovation skills, a detailed understanding of software development and design control procedures, and collaboration with other functions, external suppliers and consultants. Accountabilities/Responsibilities: Provide technical leadership and mentorship for device deliverables of regulated digital therapeutics and other software device products developed for clinical evaluation, commercialisation and subsequent lifecycle management. Work in collaboration with the Product Owner to lead device software aspects of development projects to achieve project targets in a timely fashion to agreed quality standards. Plan and review work to ensure that agreed objectives, timescales and budgets are met. Lead specific device development activities and deliverables e.g. Risk Assessments, Design Reviews and prepare 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. Demonstrate creativity and problem solving leading to a breadth of impact across the business in the Software Medical Device area Be recognized internally and externally as a specialist in Software Medical Devices remaining current in development approaches and technologies 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 Product Owner, 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 Contribute to the training and development of new team members by acting as coach/mentor as appropriate. Provide disciplinary scientific leadership and present work through patents, publications and lectures. Minimum Requirements -Education and Experience * Degree and/or post-graduate qualification in a relevant subject * 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. * Proven 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 * Excellent document writing and reviewing skills * Advantageous to have experience of preparing regulatory documentation (ideally in CTD format) Date Posted 02-Apr-2020 Closing Date 15-May-2020 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.