Senior R & D Engineer

Our Client a cutting edge medical device company based in Galway are hiring a Senior R & D Engineer to join the team.

Product Development and Design

• Lead 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.

Lead 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 Development

• Build 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.

Build 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 Compliance

• Collaborate 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.

Collaborate 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 Execution

• Take 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.

Take 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 Collaboration

• Work 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.

Work 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.