Senior R&D Engineer - County Wexford

Senior R&D Engineer - County Wexford.

This position can be offered as a hybrid role, with 3 days on site.

This position works cross-functionally to lead research and development efforts of complex medical devices. The position designs, develops and implements new products, focusing on chemistry development and scale up, project planning, innovative medical device design, prototype development, testing characterisation, analysis and reporting.

Main responsibilities will include:
• Designs, develops and implements new products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings and makes and presents engineering decisions.
• Participates and leads cross-functional teams in the design of a medical device and contributes ideas and/or generates intellectual property submissions.
• Develops new chemistries for medical devices and contributes to the scale-up of chemical processes to production readiness.
• Develops new processes by understanding key process inputs and outputs, using statistic methods such as DOE as appropriate.
• Develops new process equipment and tooling, including specification development, vendor selection and negotiation.
• Write and review product development plans, design reviews, technical documents and reports.
• Prepare and approve verification and validation protocols and reports and develop and implement procedures/policy.
• Develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods.
• Conduct engineering and competitor evaluations, and development unit testing.
• Plan, develop, execute and manage verification and validation activities for new products and processes.
• Train technicians and engineers on new design and process development as well as new test methods.
• Mentor/coach R&D technicians and engineers through New Product Development activities.
• Support Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
• Support/lead design and process root cause analysis and support non-conforming product and complaint investigations.

Interested applicants should have:
• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
• At least 6-9 years' industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
• Demonstrated hands-on technical aptitude.
• Chemistry Experience/Chemical Engineering Experience a plus
• Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialisation; ability to execute validation.
• Ability to create and execute project plans.
• Ability to lead cross-functional teams.
• Basic tooling, design and drafting knowledge.
• Excellent oral and written communication skills.
• Ability to analyse data, interpret results, and write reports. Proficient in statistical software.