Are you interested in taking the next step in your career with a global leader in medical devices and healthcare? Are you ready to challenge yourself? Are you an experienced NPI Engineer with a background in new product development, process validation and mechanical engineering? You could be the perfect candidate for this opportunity Don't hesitate, apply today
Job Description
Our client are seeking an experienced Process Validation Engineer to provide technical leadership in process validation and new product introduction (NPI) within their facility in Cork. This is a senior, hands-on leadership role responsible for driving validation strategy, production ramp-up, and continuous process improvement while providing direction and mentorship to junior engineers and technicians. You will lead complex engineering and validation projects, resolve yield and process performance issues, and influence design and manufacturing decisions from development through commercial release.
Key Responsibilities
* Lead process validation and qualification activities for new products and process improvements
* Provide technical and leadership direction to junior members of the team
* Drive NPI activities, supporting design transfer and ramp-up to commercial manufacturing
* Develop and execute verification and validation plans, protocols, and reports
* Apply structured problem-solving and statistical analysis to resolve complex technical and yield issues
* Support lean manufacturing, continuous improvement, and cost reduction initiatives
* Influence design direction and manufacturing strategy across projects
* Communicate technical progress and risks to cross-functional stakeholders and senior management
* Mentor others in design controls, risk management, and regulatory-compliant engineering practices.
Key Requirements
* 10+ years' experience in medical device process development, validation, or NPI
* Proven leadership experience guiding junior engineers in regulated environments
* Strong knowledge of process validation, risk analysis, and design controls
* Experience with catheter-based or complex medical devices strongly preferred
* Solid understanding of manufacturing processes
* Excellent communication skills with the ability to influence cross-functional teams
* Bachelor's degree in Engineering (Mechanical, Polymer, Biomedical, or related discipline).
Benefits
* Competitive and attractive employee compensation package
* Pension contributions
* Health insurance
* Paid holidays
Location:
Cork, Ireland
Desired Skills and Experience
Key Responsibilities
* Lead process validation and qualification activities for new products and process improvements
* Provide technical and leadership direction to junior members of the team
* Drive NPI activities, supporting design transfer and ramp-up to commercial manufacturing
* Develop and execute verification and validation plans, protocols, and reports
* Apply structured problem-solving and statistical analysis to resolve complex technical and yield issues
* Support lean manufacturing, continuous improvement, and cost reduction initiatives
* Influence design direction and manufacturing strategy across projects
* Communicate technical progress and risks to cross-functional stakeholders and senior management
* Mentor others in design controls, risk management, and regulatory-compliant engineering practices
Key Requirements
* 10+ years' experience in medical device process development, validation, or NPI
* Proven leadership experience guiding junior engineers in regulated environments
* Strong knowledge of process validation, risk analysis, and design controls
* Experience with catheter-based or complex medical devices strongly preferred
* Solid understanding of manufacturing processes
* Excellent communication skills with the ability to influence cross-functional teams
* Bachelor's degree in Engineering (Mechanical, Polymer, Biomedical, or related discipline).