Technical Product Support Engineer

At Eakin Healthcare, we put our patient at the heart of everything we do.Fifty years ago, it all started with one man’s mission: pharmacist Tom George Eakin. He saw his patients struggling with leaking urostomy pouches and decided enough was enough. He got to work and formed what would become the game-changing eakin Cohesive seal.Fast forward to today, and we’re still keeping it in the family. We’ve 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. We’re making a difference in three therapeutic areas: Ostomy, Respiratory, Surgical.We’re 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 Luxembourg.We’re good at what we do – come and join us and you can benefit from:BonusHybrid working25 days holiday plus bank holidays (rising to 28)Option to buy holiday daysWellbeing ProgrammeHealth Cash PlanPensionLife AssuranceEnhanced Maternity/PaternityCycle to Work SchemeReferral SchemeLong Service AwardsFree ParkingABOUT THE ROLE

Eakin Healthcare invests heavily in Research and Development, with a talented and innovative RandD team creating a pipeline of new products across our therapeutic areas. RandD also promotes continuous improvement across our products and services and supports the business in product changes.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 at our 3 manufacturing sites in Comber, Cardiff and Coleraine.Reporting to the Group RandD Director, this role will be integral to the Technical Product Support Team, driving product changes that entail introduction of alternative designs or materials and modifying design files to account for such changes.With demonstrable experience in product design or change engineering, the post-holder will lead design change projects and work within multi-disciplinary teams across our product ranges to ensure regulatory compliance and fulfilment of user needs.KEY ACTIVITIESTake a leading role in the design and adoption of pro-active or reactive changes to existing products, ensuring they remain fit for purpose and suitable for medical devices.Deliver design change projects in a timely manner, within budget, whilst managing project risk and keeping key stakeholders informed.Refine concepts through prototyping, functional lab testing and evaluation.Ensure product designs are fit for purpose, feasible and designed to cost.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 product design and technical knowledge to activities and business decision making within your specialty area.Undertake diligent laboratory testing, including creation 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.OtherTo adhere to the company’s 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 company’s Health and Safety policy.To adhere to the company’s Quality policy and Environmental policy.To undertake other duties as may be reasonably required.KEY SKILLSEssentialEducated to Degree level in Product Design, Mechanical Engineering, Change Engineering or closely related technical qualification.Previous experience in a similar product change role, within a manufacturing environment.Able to demonstrate expertise in understanding user requirements, developing ideas, turning them into concepts and refining them into commercial products.An understanding of medical device design files and associated change procedures.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.DesirableExperience gained in a medical device company, in a similar role.Proficient in both 2D and 3D CAD / surface modelling, preferably Solidworks.Experience in packaging design.Working knowledge of MDR, ISO 13485 compliance.Understanding of international regulatory requirements, such as US FDA and Japan FDA.Familiar with electronic document management systems, project management software and statistical software.Knowledge and understanding of plastic injection moulding, tooling and other manufacturing methods.Knowledge or understanding of Human Factors research techniques and implementation.Experience of incorporating inclusive design in product development.Experience in Photoshop/Illustrator, sketching and 3D rendering to visualise concepts/products.KEY WORKING RELATIONSHIPSInternalWorking with the RandD team to review desired outcomes and user needs prior to any change being introduced.Collaborating with the Industrialisation and Operations teams to ensure alternative designs 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.ExternalSuppliersExternal Consultants and HCPUniversitiesTest housesOur Medical device usersADDITIONAL INFORMATIONRequired to travel from time to time to support activities at other sites, attend conference / trade events and meet with suppliers.COMPETENCIESTech SavvyAnticipating and adopting innovations in business-building digital and technology applications.Decision QualityMaking good and timely decisions that keep the organization moving forward.Action OrientedTaking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.Optimizes Work ProcessesKnowing the most effective and efficient processes to get things done, with a focus on continuous improvement.Drives ResultsConsistently achieving results, even under tough circumstances.Interpersonal SavvyRelating openly and comfortably with diverse groups of people.Communicates EffectivelyDeveloping and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences.Nimble LearningActively learning through experimentation when tackling new problems, using both successes and failures as learning ..... full job details .....