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At Eakin Healthcare, we put our patient at the heart of everything we do. We’re a company with a long history of developing medical devices across three therapeutic areas: Ostomy, Respiratory and Surgical, exporting to over 60 countries.
About the Role
Eakin Healthcare invests heavily in R&D and is creating a Technical Product Support Team to provide focus and expertise for changes to existing products and services. The team will cover our core therapeutic areas with personnel located at our three manufacturing sites (Comber, Cardiff and Coleraine). Reporting to the Group R&D Director, this role will be integral to the Technical Product Support Team, driving product changes that may include alternative designs or materials and updating design files accordingly. The successful candidate will have demonstrable experience in product design or change engineering, lead design change projects, and work with multi-disciplinary teams to ensure regulatory compliance and fulfilment of user needs.
Key Activities
* Take a leading role in the design and adoption of proactive or reactive changes to existing products, ensuring they remain fit for purpose for medical devices.
* Deliver design change projects in a timely manner and within budget, while 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.
* Determine sustainability benefits of new designs or material changes.
* Contribute as a matrix team member to allocated work-streams within product change projects, meeting targets and ensuring products meet customer and operational needs.
* Provide input to technical reports and design documentation for internal and external review, ensuring accuracy.
* Adopt a continuous improvement approach and participate in relevant training to deliver business needs.
* Provide product design and technical knowledge to business decisions within your specialty area.
* Undertake laboratory testing, create test protocols, design and procure test apparatus, analyse results and write reports.
* Author, review and/or approve documentation such as test reports, regulatory and NPI documents, design reviews and specifications.
* Maintain and calibrate test apparatus and analytical equipment; create and review work instructions and risk assessments.
Key Skills
* Degree level in Product Design, Mechanical Engineering, Change Engineering or closely related technical qualification.
* Experience in a similar product change role within a manufacturing environment.
* Ability to understand user requirements, develop ideas, translate them into concepts and refine into commercial products.
* Understanding of medical device design files and change procedures.
* Strong communication skills with ability to present and defend product changes.
* Planning, prioritising and coordinating work with others.
* Experience with test development and execution, data collection, analysis and statistics.
* Experience in a medical device company in a similar role.
* Proficient in 2D/3D CAD, preferably SolidWorks; working knowledge of MDR and ISO 13485.
* Knowledge of international regulatory requirements (e.g., US FDA, Japan FDA).
* Familiar with electronic document management systems, project management software and statistical software.
* Knowledge of plastic injection moulding, tooling and other manufacturing methods.
* Understanding of Human Factors research techniques and inclusive design in product development.
* Experience with Photoshop/Illustrator, sketching and 3D rendering to visualize concepts/products.
Key Working Relationships
Internal
* R&D team to review outcomes and user needs before changes are introduced.
* Industrialisation and Operations teams to consider production impact of alternative designs.
* Procurement teams to support sourcing and supply chain assessment of materials.
* Quality and Regulatory teams to coordinate change processes and maintain standards and compliance.
* Commercial teams to ensure product changes maintain competitiveness and meet user needs.
External
* External Consultants and Healthcare Professionals
* Universities
* Test houses
Additional Information
* Occasional travel to other sites, conferences/events, and supplier meetings.
Competenicies
Tech Savvy – Anticipating and adopting innovations in digital and technology applications.
Decision Quality – Making good and timely decisions that keep the organization moving forward.
Action Oriented – Taking on opportunities and challenges with urgency and energy; focused on continuous improvement.
Drives Results – Consistently achieving results, even under tough circumstances.
Interpersonal Savvy – Relating openly with diverse groups.
Communicates Effectively – Delivering clear communications for different audiences.
Nimble Learning – Actively learning through experimentation and reflection.
Seniorität level
* Associate
Employment type
* Full-time
Job function
* Medical Equipment Manufacturing
Note: This refined description retains the core responsibilities, qualifications and context of the Technical Product Support Engineer role while removing irrelevant postings and boilerplate.
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