Lead Mechanical Design Engineer

Lead Mechanical Design Engineer Location

Munster Region, Ireland

Working Pattern

Predominantly onsite, minimum four days per week

Overview

A leading medical technology organisation in the Munster region is seeking an experienced Lead Mechanical Design Engineer to take a senior technical and leadership role within a regulated product development environment.

This position has responsibility for the design, development, and verification of complex medical devices, including both capital equipment and disposable components. The role combines hands on engineering delivery with project leadership, mentoring, and cross functional collaboration across the full product lifecycle.

Key Responsibilities

• Lead the mechanical design, development, and verification of complex assemblies, sub assemblies, components, and packaging
• Translate product and user requirements into clear, robust technical specifications
• Select appropriate materials, manufacturing processes, tooling, automation, and equipment
• Conduct feasibility studies, engineering analysis, and proof of concept testing
• Drive design and process improvements focused on performance, quality, cost, and manufacturability
• Lead risk management activities including PHA, FTA, dFMEA, and uFMEA
• Perform root cause analysis and implement corrective actions following failure investigations
• Work closely with manufacturing and operations teams to resolve technical issues and optimise processes
• Manage projects or sub projects, coordinating cross functional teams and timelines
• Apply structured project management and product development lifecycle methodologies
• Provide technical support to suppliers and subcontract manufacturing partners
• Lead and contribute to technical design reviews with internal and external stakeholders
• Stay current with emerging technologies, tools, and best practice
• Support team leadership activities including mentoring, coaching, and recruitment input
• Plan, prioritise, and coordinate daily activities to ensure delivery against programme objectives

Experience and Qualifications

• Degree qualified in Mechanical Engineering, Biomedical Engineering, or a related discipline
• Six to nine years experience in medical device mechanical design engineering
• Minimum five years experience leading design projects or technical teams
• Proven background working on both capital equipment and disposable medical devices
• Strong understanding of engineering fundamentals, documentation control, and structured problem solving
• High level proficiency in GD&T and application in design and inspection
• Experience with Design for Six Sigma, statistical analysis, and DOE
• Deep knowledge of materials, manufacturing techniques, and design for manufacturability and assembly
• Experience working within regulated quality systems including ISO 13485, MDR, and FDA CFR 820
• Familiarity with Stage Gate or structured product development lifecycle frameworks
• Strong communication, leadership, and stakeholder management skills
• High attention to detail with a quality focused mindset

Additional Information

This opportunity would suit a senior mechanical engineer who enjoys technical leadership, mentoring others, and delivering high reliability products in a regulated MedTech environment. Due to the nature of the role and required cross functional integration, a strong onsite presence is essential.