Our client a Major Multinational here in Galway are looking to hire a Principal Design Assurance Engineer.
The Principal Design Assurance Engineer role will be instrumental in shaping the Design Control strategy to support our IDEM new product development pipeline. They will champion and drive improvement in our processes, provide direction to and ensure compliance across all our supporting organizations – R&D, Marketing, QA, RA, Clinical Operations, and Manufacturing.
- Be a leader in design control and build organizational capabilities across IDEM design sites.
- Embed Design Assurance in all stages of the design control process from concept and feasibility through to product launch and post-market surveillance.
- Review and remediation of current Design Control procedures and practices across sites to standardize to “best in class” design controls. Liaise with quality systems, clinical and medical affairs, and regulatory affairs personnel within the Business Unit to ensure team’s compliance and to drive alignment and harmonization.
- Development of effective training collateral to ensure compliance to design control policies with the Core Teams, Extended teams, and relevant functions within the Business Unit.
- Champion and implement clinical compliance processes to support clinical operations and ensure that regulatory and ethics boards requirements are met through clinical studies.
- Provide Design Assurance Core Team Oversight and direction;
- Perform technical reviews of design documentation and labeling, attend core team meetings and design reviews, coordinate and facilitate completion and update of design risk management documentation and act as an independent reviewer for all design activities including design changes.
- Provide oversight on the development of new test methods and appropriate test method validation.
- Provide direction on anomalies identified in design deliverables through data-based investigation and robust corrective action.
- Design Control Support for audits including Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO). Take the lead and front the team’s participation in audits.
- Manage a team of Design Assurance Engineers as the organization grows and develops.
- Demonstrate ability to work in a matrix organization where project deliverables are accountable to the Program/ Workstream Leader.
- Primary Degree level qualification in Science, Engineering or Technology, plus 10 years of Quality Engineering/ Design Assurance work experience within a regulated environment (ISO13485/ FDA) most recently within the area of design controls.
- Formal training in Medical Device Risk Management, Clinical Evaluations, Process Validation, and problem-Solving would be beneficial.
- Proven ability to lead a team.
- Excellent data analysis skills.
- Demonstrated experience in working in a diverse cultural environment.
- Excellent presentation skills to facilitate communication throughout the organization. In addition, excellent use of virtual communication technology is required for effective workshop leadership and change management.
- Travel pending company policy, global and country regulations to Asia and Europe.
For a confidential discussion and more information about the role please contact Michelle Mc Inerney
091 706 717