Our Client a cutting edge medical device company based in Galway are hiring a Senior R & D Engineer to join the team.Responsibilities include but are not limited to:Product Development and DesignLead product development from concept through to manufacturing readiness, ensuring products are safe, effective, and user-focused.Contribute to technical reviews, interpret experimental data, and influence design direction through brainstorming sessions.Develop prototypes and refine designs using techniques such as vacuum forming, injection moulding, dip moulding, heat sealing, laser cutting, and 3D printing.Evaluate and source materials, components, and suppliers to optimize design and manufacturability.Communicate design decisions clearly, interpret research literature and test results to enhance product designs.Create and maintain comprehensive design documentation, including drawings, specifications, technical reports, user needs, product requirements, and traceability matrices.Testing, Analysis, and DevelopmentBuild prototypes to validate design concepts and ensure safety and effectiveness.Develop and implement test methods for product safety and performance validation.Predict design outcomes through mathematical modelling, digital analysis, and experimental validation.Utilize user testing groups to gather real-world insights and iterate on designs.Collaborate with the Verification & Validation (V&V) engineer to validate test methods for design verification.Quality Assurance and ComplianceCollaborate with design assurance teams to conduct risk assessments using Failure Mode and Effects Analysis (FMEA).Ensure all product designs comply with relevant regulatory standards, including FDA guidance, MDR, ISO 13485, and IEC 60601.Maintain Design History File (DHF) documentation, including Design Inputs, Test Method Design & Validation, and Design Verification Plans.Project Leadership and ExecutionTake ownership of critical and complex technical tasks, driving project success and maintaining timelines.Collaborate with the R&D Lead, Project Manager, and RA/QA teams to ensure project alignment and uphold quality standards.Manage external suppliers and manufacturing partners, ensuring timely delivery and alignment with project goals.Provide technical leadership and mentorship to junior team members, fostering growth and expertise within the team.Cross-functional CollaborationWork closely with manufacturing engineers to ensure Design for Assembly (DFA) throughout the design process.Lead cross-functional teams to develop user-focused medical devices that improve patient outcomes.Participate in technical discussions, contributing ideas to enhance product functionality and manufacturability.Experience and Expertise:Minimum of 6+ years of R&D experience, with at least 4+ years in the medical device sector.Proven track record in product design and development, including design for assembly/manufacturing.Expertise in Design History File (DHF) documentation and Design Verification Plans.Hands-on experience with manufacturing processes such as injection moulding, vacuum casting, dip moulding, and rapid prototyping (3D printing).Strong understanding of medical device regulatory requirements, including FDA guidance, MDR, ISO 13485, and IEC 60601.Technical Skills:Proficiency in developing robust test methods for evaluating designs and guiding iterations.Familiarity with Quality Management Systems (ISO 13485) and compliance with industry standards.Experience with risk assessments using Failure Mode and Effects Analysis (FMEA).Leadership and Collaboration:Proven ability to lead cross-functional teams and collaborate effectively across departments.Experience in managing external suppliers and manufacturing partners.Strong communication and collaboration skills, with the ability to convey complex technical concepts clearly.Personal Attributes:Creative: Problem solver with enthusiasm for exploring innovative solutions.Open and Collaborative: Team player who actively contributes to a positive company culture.Communicative: Proficient in written and verbal communication, able to articulate ideas effectively.Self-Driven and Organized: Highly motivated with a sense of urgency and the ability to manage multiple tasks.Methodical Approach: Structured and analytical in problem-solving and product development.Experience Advantages – Preferred but Not RequiredExperience working with wearable products involving textiles.Proficiency in CREO CAD software.Experience in design for sterilization.Familiarity with testing autoinjectors and/or vascular access devices.Prior experience designing and executing usability studies, incorporating human factors into product design.Experience with electromechanical and pneumatic device designNote: 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-