Our client, a HPSU medical device company is hiring a Senior Research and Design Engineer to join their team in Galway.
The successful candidate will become the next key player in our R&D team and a leading member in taking our Clients' device from the proof of concept phase to a user friendly, market-ready product.
The role will involve taking on complex mechanical design tasks and working with suppliers to ensure manufacturing feasibility.Responsibilities include but are not limited to the following:Become a technical contributor within the R&D group to drive patient-focused cancer care products from idea to manufacture, including:Contributing to technical reviews, interpreting data from experimental work, and influencing design direction through product brainstorms.Developing concepts through to manufacture-readiness using techniques such as vacuum-forming, injection moulding, dip moulding, and blow moulding, among others.Drive the design of patient-focused cancer care products from concept to manufacture, including: Leading the completion of tasks and projects through a methodological and planned approach to product development.Exploring and vetting materials, components and suppliers.Communicating design decisions, interpreting literature and test results, and influencing design direction.Generating new design ideas and concepts that meet the overarching design requirements.Testing, analysis, and development of design concepts for novel medical devices through:Building prototypes to prove concept effectiveness; Creating test methods to accurately and repeatably demonstrate safety and effectiveness; Predicting design outcomes through mathematical calculations, digital analysis, and physical design experimentation & Utilising user testing groups to test product designs in the real world, documenting insights and iterating on concepts.Take responsibility for the delivery of project goals and personal responsibility for critical and complex technical tasks.Working closely with the R&D Lead, Project Manager and RA/QA team to maintain agreed timelines and ensure quality standards are maintained.Ensure the delivery of projects in a timely fashion by working closely with, guiding, and building relationships with external suppliers and manufacturing partners, managing their time effectively and maintaining agreed timelines.Providing technical leadership and mentoring to less experienced team members.Worked on several product design or development projects, with 6+ years of experience in an R&D role and at least 4 years of experience in the medical device sector.Experience with directly contributing to Design History File documents such as Design Inputs, Test Method Design and Validation, and Design Verification Plans alongside experience writing formal testing protocols and test reports.Clear ability to create robust tests for evaluating designs, predicting outcomes and determining iteration requirements.Experience working towards and carrying out Design Verification testing.A strong understanding of medical device regulatory requirements and applicable standards.An ability to demonstrate a methodological and planned approach to product development.Experience working within a Quality Management System to ISO13485 standards.It Would Be Advantageous to Have: Demonstrable examples of design for assembly/manufacture experience ; Knowledge of a wide variety of manufacturing processes, such as injection moulding, vacuum casting, dip moulding, joining technologies, and rapid prototyping (3D printing); Experience working with wearable products that involve textiles.
; CAD experience (we use CREO, but we can provide training), general modelling and drafting 2D drawings.
; Prior experience designing and executing usability studies and incorporating human factors considerations into the product design.
; Comfortable with rapid prototyping using FDM, SLS and SLA 3D printing.
Can demonstrate understanding of the limitations of rapid prototyping and experienced in using machined prototypes.
Good benchtop skills for manufacturing prototypes.As this is a key early hire at a rapidly growing company.
You will have an opportunity to shape the development of multiple high-impact patient-facing products and gain first-hand insights into the growth of a start-up.
Our Client offers a highly competitive salary (available on application), a flexible benefits package, alongside with all the necessary equipment to succeed in the role.
This role is also offering flexible working hours and a generous vacation policy.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
