A fantastic opportunity has just opened up with our leading Medtech Client for a Research and Development Engineer.Responsibilities include but are not limited to:Product Development and DesignConcept to Manufacture: Drive product development from proof of concept through to manufacturing readiness, ensuring safety, effectiveness, and user-focused design.Technical Review and Analysis: Contribute to technical reviews, interpret experimental data, and participate in brainstorming sessions to influence design direction.Prototyping and Iteration: Develop prototypes using techniques such as vacuum forming, injection moulding, dip moulding, heat sealing, laser cutting, and 3D printing to validate design concepts.Design Documentation: Create and maintain comprehensive design documentation, including drawings, specifications, technical reports, and requirements documentation.Material and Supplier Evaluation: Evaluate and source materials, components, and suppliers to optimize design and manufacturability.Design Communication: Effectively communicate design decisions, interpreting research literature and test results to enhance product designs.Risk Management and Compliance: Collaborate with design assurance to conduct risk assessments through Failure Mode and Effects Analysis (FMEA).Design for Assembly (DFA): Work closely with manufacturing engineers to ensure DFA principles are integrated throughout the design process.Testing, Analysis, and DevelopmentFeasibility and Verification Testing: Develop test methods to assess feasibility and verify design requirements, ensuring product safety and effectiveness.Prototyping and Validation: Build prototypes to validate design concepts, using iterative testing and feedback to optimize designs.Experimental Analysis: Utilize experimental data and user feedback to refine designs, ensuring high standards of safety, usability, and effectiveness.Project Leadership and ExecutionTechnical Ownership: Take personal responsibility for critical and complex technical tasks, driving project success and maintaining timelines.Cross-functional Collaboration: Collaborate closely with Senior Engineers, Project Manager, and RA/QA teams to ensure project alignment and quality standards.Timeline and Goal Management: Manage project timelines effectively, ensuring on-time delivery of project goals while maintaining high-quality standards.Continuous Improvement and InnovationDesign Optimization: Continuously improve product designs by incorporating new technologies, materials, and methods.Creative Problem Solving: Leverage creative problem-solving skills to overcome design challenges and drive innovation.Educational Background:Minimum Level 8 degree in Engineering, as per the National Framework of Qualifications (NFQ) Ireland.Professional Experience:2-5 years of experience in product development, preferably within the medical device industry. (Eng I and II will be considered) Experience in design for assembly (DFA) for mid to high-volume manufacturing of medical devices and/or consumer products.Proven track record in CAD modelling of complex geometries and assemblies for consumer devices.Knowledge of manufacturing processes, including injection moulding and rapid prototyping (3D printing).Experience creating documentation for Medical Device Design History Files, including Risk Management, Design Inputs, Test Method Design, and formal testing protocols and reports.Demonstrated experience working towards medical device regulatory requirements and standards, including FDA guidance, MDR guidance, ISO 13485, and IEC 60601.Methodical and structured approach to product development, with strong problem-solving and analytical skills.Technical SkillsCAD Proficiency:Proficiency in CAD modelling (experience with CREO is preferred but not mandatory).Ability to design complex geometries and assemblies for medical devices and consumer products.Testing and Validation:Hands-on experience with feasibility testing, verification testing, and test method development.Ability to create robust test methods and analyze test data to guide design iteration.Communication and Collaboration SkillsCross-functional Collaboration:Strong collaboration skills with cross-functional teams, including R&D, Manufacturing, Design Assurance, and Regulatory Affairs.Stakeholder Communication:Excellent verbal and written communication skills, with the ability to clearly convey design decisions and technical information to stakeholders.Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.-Pale Blue Dot® Recruitment - The Resource for the MedTech Workforce-