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 Design
* Concept 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 Development
* Feasibility 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 Execution
* Technical 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 Innovation
1. Design Optimization: Continuously improve product designs by incorporating new technologies, materials, and methods.
2. Creative Problem Solving: Leverage creative problem-solving skills to overcome design challenges and drive innovation.
* Educational Background:
o Minimum Level 8 degree in Engineering, as per the National Framework of Qualifications (NFQ) Ireland.
* Professional Experience:
o 2-5 years of experience in product development, preferably within the medical device industry. (Eng I and II will be considered)
o Experience in design for assembly (DFA) for mid to high-volume manufacturing of medical devices and/or consumer products.
o Proven track record in CAD modelling of complex geometries and assemblies for consumer devices.
o Knowledge of manufacturing processes, including injection moulding and rapid prototyping (3D printing).
o Experience creating documentation for Medical Device Design History Files, including Risk Management, Design Inputs, Test Method Design, and formal testing protocols and reports.
o Demonstrated experience working towards medical device regulatory requirements and standards, including FDA guidance, MDR guidance, ISO 13485, and IEC 60601.
o Methodical and structured approach to product development, with strong problem-solving and analytical skills.
Technical Skills
* CAD Proficiency:
o Proficiency in CAD modelling (experience with CREO is preferred but not mandatory).
o Ability to design complex geometries and assemblies for medical devices and consumer products.
* Testing and Validation:
o Hands-on experience with feasibility testing, verification testing, and test method development.
o Ability to create robust test methods and analyze test data to guide design iteration.
Communication and Collaboration Skills
* Cross-functional Collaboration:
o Strong collaboration skills with cross-functional teams, including R&D, Manufacturing, Design Assurance, and Regulatory Affairs.
* Stakeholder Communication:
o 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-