Senior Design Assurance Engineer
- The purpose of this job is to help with product development and sustaining engineering activities while supervising, leading and coaching members of the design assurance department.
- Work cross functionally across R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing helping to drive improvements in product and process quality.
- Provide guidance and support for design control and sustaining engineering activities.
- Work closely with quality on design reviews, design plans, risk management, design verification and NPD projects.
- Partner with the quality systems and regulatory affairs divisions on compliance projects and product development activities.
- Monitor and implement changes in global and regional quality and regulatory policies both internally and externally.
- Utilize statistical analysis from product testing to resolve issues.
- Level 8 degree in a Science or Engineering with 5 years or more experience in medical devices.
- Must have a working knowledge of EN ISO 5840-3.
- Should have a basic understanding of Finite Element Analysis and Kinematics.
- Knowledge of Nitinol or Materials of animal origin desirable.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: email@example.com
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