Overview
We are seeking an experienced Senior Engineer in Cork, Ireland for a 12-month contract. This role will provide technical leadership across manufacturing, design support, and process improvement activities within a highly regulated environment. The successful candidate will be a hands-on engineer with strong problem-solving capabilities and experience supporting quality, safety, and performance requirements for medical devices. Experience with Coordinate Measuring Machines (CMM) is required. Metrology experience is highly desirable.
Key Responsibilities
Act as a subject matter expert (SME), providing technical guidance across mechanical, manufacturing, and/or supporting software systems.
Support product safety, performance, and compliance with applicable medical device regulations and quality standards.
Partner effectively with cross-functional teams including Quality, Manufacturing, R&D, and Regulatory Affairs.
Problem Solving & Quality
Lead complex troubleshooting activities in a manufacturing environment.
Conduct structured root cause investigations using established problem-solving methodologies.
Perform and support Non-Conformance (NC) investigations, CAPA, and deviation management.
Drive timely and sustainable resolution of quality and manufacturing issues.
Design & Development
Utilize CAD/CAE tools for modeling, analysis, and design support.
Participate in PFMEA (Process Failure Mode and Effects Analysis) and risk management activities.
Support verification and validation activities for new and existing products.
Contribute to New Product Introduction (NPI) and design transfer activities.
Process Improvement
Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma tools.
Support Design for Manufacturing (DFM) and process optimization.
Identify and implement opportunities to improve efficiency, reduce waste, and enhance product quality.
Six Sigma Green Belt or Black Belt certification preferred.
Metrology & Measurement
Apply hands-on experience with CMM for dimensional inspection, verification, and reporting.
Support metrology strategies, measurement system analysis, and tolerance assessments.
Experience with precision measurement in a regulated manufacturing environment is a strong advantage.
Typical Qualifications
Education & Experience
Bachelor's degree in Mechanical Engineering or a related discipline with 6+ years of relevant industry experience, or
Master's degree with 2+ years of relevant experience, or
PhD in an engineering discipline.
Prior experience in medical devices or other regulated industries is strongly preferred.
Strong analytical and technical problem-solving skills.
Proficiency with CAD/CAM and engineering analysis tools.
Proven experience working with CMM (required).
Knowledge of regulatory and quality standards (e.g., ISO 13485, FDA QSR).
Excellent communication skills and ability to collaborate across multidisciplinary teams.
Ability to operate independently and provide leadership in a contract role.
Desired Skills and Experience
CAD/CAM
Metrology
CMM
#J-18808-Ljbffr