Job Title:
Lead Mechanical Design Engineer
Location:
Castletroy, Limerick (4 days onsite)
Type:
Permanent
About the Role
We are seeking a highly skilled
Lead Mechanical Design Engineer
to drive the design, development, and verification of complex medical devices, including both capital equipment and disposable components. This role blends technical depth with leadership, requiring a strong background in mechanical and mechatronic systems, manufacturing processes, and regulatory compliance. You'll be accountable for delivering robust, innovative, and manufacturable solutions while guiding and mentoring a design team.
Key Responsibilities
* Lead and manage the design, development, and verification of assemblies, sub-assemblies, components, and packaging.
* Define and translate product requirements into comprehensive specifications.
* Select materials, processes, tooling, automation, and equipment to align with design and manufacturing needs.
* Conduct feasibility studies, proof-of-concept testing, and systematic technical analysis.
* Drive continuous design and process improvements to optimize performance, quality, and cost.
* Lead risk assessments (PHA, FTA, dFMEA/uFMEA) for product and manufacturing processes.
* Investigate root cause failures and implement corrective actions.
* Partner with manufacturing teams to troubleshoot issues and optimize parameters.
* Manage projects or sub-projects, assigning tasks and guiding cross-functional teams.
* Apply structured project management methods, ensuring effective stakeholder communication.
* Research, evaluate, and integrate emerging technologies and tools.
* Oversee recruitment, performance management, and development of direct reports.
* Coordinate and prioritize daily activities to meet deliverables on time.
* Provide technical guidance to suppliers and subcontractors.
* Lead technical reviews and deliver presentations across internal and external teams.
About You
* Bachelor's or Master's degree in Mechanical or Biomedical Engineering (or equivalent).
* 6–9 years' experience in medical device design engineering, with
5+ years leading mechanical design teams
.
* Proven background in developing both capital equipment and disposable components.
* Strong expertise in GD&T, Design for Six Sigma (DFFS), DOE, and statistical analysis.
* Solid knowledge of materials, manufacturing processes, and design for manufacturability/assembly.
* Strong foundation in engineering principles, documentation control, and root cause analysis.
* Demonstrated leadership with ownership of deliverables and team outcomes.
* Excellent communication skills and experience managing cross-functional teams.
* Familiar with medical device quality and regulatory systems (EN ISO13485, MDR, FDA CFR 820).
* Knowledge of Stage-Gate or Product Development Life Cycle processes.