Donna Kesteven

WORK HISTORY

EDUCATION

SKILLS

ABOUT DONNA KESTEVEN

MChem graduate (Chemistry with Forensic and Analytical Science) in 2010. 14 years experience within R&D of medical devices in both small and large company structures, which has allowed me to gain different insights to development approaches. Confident, consistent and practical, I am persistent and thrive within a challenging environment.Well organised and work effectively and flexibly, both as an individual and as a member of a team. I communicate well with others. I comfortably take on the lead role within a team and am very delivery/results focused. SkillsProduct development – Scale up development through to delivery of medical devices (wound dressings). Responsibility for management of design and development. I am APMP level D and PRINCE2 foundation certified. I have a broad understanding of all cross functions required to deliver a product to market.Regulatory – Experience in the development of products in accordance with the Medical Device Directive (MDD), Medical Device Regulations (MDR) and FDA.Manufacturing - Planning & implementation of development trials, verification and validations within the wound dressing arena.Design Control – Risk Management (ISO 14971) & Design Transfer (ISO 13485).Change Control - I have executed multiple design changes to Class IIB and devices post launch with a logical and strategic approach, ensuring changes accurately balance the risk of the change with the effort required to deliver it. These changes were a variety of product improvements and margin improvement to save several million dollars per annum.Biocompatibility - A certified Biological Safety Specialist, I am trained in ISO 10993 assessments, with experience of E&L and basic toxicological assessments.