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.