AtEakin Healthcare we put our patient at the heart of everything we do. Fifty years ago, it all started with one mans mission: pharmacist, Tom George Eakin. He saw his patients struggling with leaking urostomy pouches and decided enough was enough. He got to work and formulated what would become the game-changing, eakin Cohesive seal. Fast forward to today, and were still keeping it in the family. Weve grown a lot since then, both organically and through acquisitions. We now have a team of over 700 colleagues across three manufacturing sites and 12 sales and distribution centres. Were making a difference in three therapeutic areas: Ostomy Respiratory Surgical Were proud to export our innovative products to over 60 countries through a network of 40 distributors plus our own offices in Japan, The Netherlands, France, Germany, Belgium and Luxemburg. Were good at what we do come and join us and you can benefit from: Blended Working Bonus 25 days holiday plus bank holidays (rising to 28) Option to buy holiday days Wellbeing Programme Health Cash Plan Pension Life Assurance Enhanced Maternity/Paternity Cycle to Work Scheme Referral Scheme Long Service Awards Free Parking ABOUT THE ROLE Eakin Healthcare invest heavily in Research & Development,with a talented and innovative R&D team creating a pipeline of new products across our therapeutic areas. R&D also promote continuous improvement across our products and services and support the business in product changes. In recognition of the need to provide focus and expertise for changes to existing products and services, we are creating a Technical Product Support Team with a range of skills and knowledge to cover our core therapeutic areas, with personnel located in our 3 manufacturing sites at Comber, Cardiff and Coleraine. Based in Comber and reporting to the Group R&D Director, this role will be integral to the Technical Product Support Team, driving product changes that entail introduction of new materials, biocompatibility assessments and building on our adhesive formulation knowledge. KEY ACTIVITIES Take a leading role in chemical assessment of alternative raw materials for existing products, ensuring they are fit for purpose and suitable for incorporation into our medical devices. Conduct biocompatibility assessments for new materials or for complete products incorporating these, to ensure biological safety, in line with appropriate ISO standards. Deliver formulation or material change projects in a timely manner, within budget, whilst managing project risk and keeping key stakeholders informed. Take a lead role in determining sustainability benefits of any new designs or material changes. Contribute as a matrix team member to allocated work-streams within product change projects, meeting project targets and ensuring products meet customer expectations and operational needs. Provide input to technical reports and design documentation for internal and external users to review ensuring that the content is accurate and informed. Adopt a continuous improvement approach, proactively seeking development opportunities through learning and attending training courses to ensure the department has the skills to deliver business needs. Provide formulation and technical knowledge input to activities and business decision making within your specialty area. Undertake diligent laboratory testing, including creation and validation of test protocols, designing and procuring test apparatus, analysis of results and report writing. Author, review and/or approve documentation, such as test reports, regulatory and NPI documents, design reviews and specification documents. Maintenance and calibration of test apparatus and analytical equipment, including creation and reviewing of work instructions and risk assessments. Other To adhere to the companys Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible To be responsible for your own health and safety and that of your colleagues, in accordance with the companys Health and Safety policy To adhere to the companys Quality policy and Environmental policy To undertake other duties as may be reasonably required KEY SKILLS Essential Educated to Degree level in Chemistry, Pharmacy, Material Science or closely related discipline. Previous experience in a similar product change role. Demonstrable expertise in formulation science, assessment of raw materials, product user requirements and adoption of alternative materials. An understanding of medical device design files and associated change procedures. Project management experience. Strong communication skills with ability for robust discussion to defend and challenge product changes, including presenting reports on experimental work. An ability to plan ahead, prioritise tasks and coordinate with the work of others. Able to demonstrate working knowledge of test development and execution, including collection, analysis and statistical interpretation of data. Desirable Experience gained in a medical device company, in a similar role. Experience in the development and manufacture of medical adhesives and the associated regulatory framework of the medical industry. Working knowledge of Polymer Science and Engineering including rheology, stabilization and surface chemistry. Working knowledge of analytical techniques such as FTIR, DSC GPC, hot stage microscopy, pressure sensitive adhesive testing. Working knowledge of design of experiments Working knowledge of MDR, ISO 13485 compliance including ISO 10993 biocompatibility. Understanding of international regulatory requirements, such as US FDA and Japan FDA. Familiar with electronic document management systems, project management software and statistical software. KEY WORKING RELATIONSHIPS Internal Working with the R&D team to review desired outcomes and user needs prior to any change being introduced. Collaborating with the Industrialisation and Operations teams to ensure new materials are considered for impact on production and processes. Contribute to a wider Change team, including the Procurement teams across the therapeutic areas, to support sourcing and assessment of raw materials and their supply chain. Working closely with the Quality and Regulatory teams to co-ordinate and control the change process and ensure product changes retain their quality standards and regulatory compliance. Build strong working relationships with our commercial colleagues across the therapeutic businesses, to ensure any product changes retain or improve their competitiveness and meet user needs. Be able to work in a multi-functional team and to build relationships with peers. External Suppliers External Consultants and HCP Universities Test houses Our Medical device users ADDITIONAL INFORMATION Required to travel from time to time to support activities at other sites, attend conference / trade events and meet with suppliers.