Senior R&D Design Engineer

Location: Galway Employment: Permanent

The Opportunity

An opportunity for an experienced Senior R&D Design Engineer to lead medical device product development projects, translating customer and user requirements into innovative, manufacturable mechanical design solutions. The role spans concept development, design verification and transfer to production, with close collaboration across engineering, quality, manufacturing and project teams.

Key Responsibilities

• Lead multiple product development projects from requirements definition and concept development through design verification and production transfer.
• Develop user-focused mechanical designs, including complex 3D CAD assemblies, surface modelling, 2D drawings and tolerance stack-up analysis using SolidWorks.
• Lead prototyping, engineering builds, pilot production trials and design troubleshooting to evaluate feasibility and mitigate technical risks.
• Prepare product specifications, design inputs/outputs, test methods and verification protocols; conduct testing to ISO 13485 and customer requirements.
• Perform design risk assessment and risk management in accordance with ISO 14971, including design and process FMEAs.
• Analyse test data using Minitab or equivalent tools; support test method development, validation and limit/challenge testing.
• Collaborate on product validation, usability testing, technical/design reviews and design transfer with production and process development teams.
• Support project planning, schedules, costings, proposals and customer presentations; investigate nonconformances and recommend design improvements.

Experience & Qualifications

• Minimum 6 years' medical device product development experience, ideally including highly regulated Class III devices.
• Strong hands-on mechanical design experience and proficiency in SolidWorks or equivalent 3D CAD software.
• Demonstrated knowledge of materials, mechanisms, plastics, manufacturing methods, design for manufacture and tolerance analysis.
• Experience working within medical device design controls, including verification/validation, risk management and associated documentation.
• Knowledge of ISO quality requirements, GMP and QSR, with experience in design/process FMEAs.
• Proven ability to lead projects, manage competing priorities and work effectively with cross-functional teams and suppliers.
• Strong problem-solving, root-cause analysis, communication and technical leadership skills; proficiency in Microsoft Office.

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