Senior Design Assurance Engineer
Work on structural heart devices, exploring the leading and most cutting edge technologies on offer for bettering patient health and safety. This position is with one of the worlds leading medical device companies withing their ever growing Galway site with a focus new product development.
This particular position will manage a technical transfer from Switzerland.
- 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: firstname.lastname@example.org
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