Senior Product Development Engineer

Location: Galway
Duration: Permanent

Role Description

This job description sets out to define the role of a Senior Product Development Engineer. The role involves leading product development activities across multiple customer projects, ensuring requirements are translated into robust, manufacturable medical device solutions.

Duties & Responsibilities

• Lead product development activities across multiple projects, ensuring customer requirements are translated into product specifications for transfer to production.
• Develop user-focused product solutions optimised for manufacture.
• Lead concept development, engineering, and design verification stages of new product development.
• Deliver mechanical design solutions for early-stage and late-stage product development.
• Perform risk assessment and risk management activities in accordance with ISO 14971.
• Prototype and test concept designs and early engineering builds.
• Develop CAD models and tolerance stack-ups using SolidWorks, including complex assemblies and surface modelling.
• Support pilot production trials to assess feasibility and mitigate design risks.
• Develop product specifications, test methods, and associated documentation.
• Perform statistical analysis of test data using Minitab or equivalent tools.
• Lead design verification activities including protocol development and execution in line with ISO 13485 requirements.
• Collaborate with design teams on product validation and usability testing.
• Lead and participate in customer design and technical reviews.
• Work closely with process development and production teams to support transfer to manufacturing.
• Support project planning, scheduling, cost tracking, and reporting activities.
• Develop project proposals outlining cost, schedule, and risk and present these to customers.
• Support quality investigations, root cause analysis, and design improvement initiatives.

Education & Experience Required

• Minimum of 6 years' experience in medical device product development, ideally within highly regulated Class III environments.
• Strong understanding of manufacturing methods, mechanisms, materials, tolerance analysis, and design for manufacturing.
• Proven mechanical design experience.
• Extensive experience translating design inputs into engineering outputs, tolerance stack-ups, and product testing.
• Strong knowledge of medical device design controls, design verification and validation, and FMEAs.
• Experience working within GMP, QSR, ISO 13485 and other relevant quality systems.
• Demonstrated experience in medical device risk management and associated documentation.
• Excellent problem-solving, decision-making, and root cause analysis skills.
• Experience designing for manufacturability, particularly for plastic components, and managing suppliers.
• Strong project management experience from concept through delivery.
• Excellent written and verbal communication skills.
• Proven experience working within and leading cross-functional product development teams.
• Proficiency in SolidWorks and Microsoft Office.

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