Job Description

Lead Mechanical Design Engineer

Location

Munster Region, Ireland

Working Pattern

Predominantly onsite, minimum four days per week

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.