Senior R&D Engineer

5 days ago

Galway City, Ireland Gi Group Full time

About the Role GI Group are hiring on behalf of our client, an innovative medical device company, for an experienced Senior R&D Engineer to join their Galway-based team.
This is a key role in the design, development, and commercialization of Class II medical devices.
The successful candidate will bring strong design control expertise and a proven track record in medical device product development.
Key Responsibilities Lead and contribute to the design and development of new medical device products, from concept through to commercialization.
Ensure adherence to design control procedures and regulatory requirements (FDA, ISO 13485, MDR).
Lead risk management activities in accordance with ISO 14971.
Generate and review design documentation including design inputs/outputs, verification and validation protocols, and technical files.
Collaborate with manufacturing, quality, and clinical teams to support design transfer, scale-up, and product launch.
Mentor junior engineers and provide technical leadership within the R&D team.
Participate in problem-solving, root cause analysis, and design improvements for existing products.
Interface with suppliers and external partners to source components and drive innovation.
Support regulatory submissions with robust technical documentation.
Qualifications & Experience Bachelor's or Master's degree in Mechanical, Biomedical, Materials, or related engineering discipline.
8+ years of experience in R&D engineering roles within the medical device industry (Class II devices preferred).
Proven experience with design control processes and regulatory compliance.
Strong background in CAD design, prototyping, and design verification/validation testing.
Knowledge of biocompatibility, sterilization methods, packaging validation, and standards (ISO 10993, ISO 11607, etc.).
Experience with DFMEA, PFMEA, and risk management methodologies.
Excellent problem-solving, analytical, and technical writing skills.
Strong project management skills with ability to lead cross-functional initiatives.
Demonstrated ability to mentor and guide junior engineers.
Preferred Skills Experience with minimally invasive devices, implantables, or catheter-based technologies.
Familiarity with regulatory submissions (510(k), CE Marking).
What's on Offer Salary: €85,000 Competitive benefits package.
Opportunity to work on cutting-edge medical technologies.
Career growth and leadership opportunities.
Collaborative and innovative work environment.
KSGalway Should you require any support or assistance, please contact your local Gi Group office.
Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, pledge members for Neurodiversity in business, Disability committed members, Silver status pledge members for the Armed Forces Covenant, and Bronze trail blazers for Racial Equality matters.
Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Ireland Limited and Kelly Services (UK) Ltd.
Gi Group Ireland Limited are acting as an Employment Agency in relation to this role.
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