Senior Design Assurance Engineer Position
We are seeking a skilled Senior Design Quality Assurance Engineer to join our team. This is an excellent opportunity for an experienced professional to lead projects related to drug-coated balloon product lines and ensure design changes are compliant with regulations and procedures.
As a Senior Design Quality Assurance Engineer, you will be responsible for leading projects, including scoping, assessment, and implementation. You will also interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams to provide technical and quality systems input.
The ideal candidate will have a deep understanding of requirements and procedures governing medical device Design Control. They will also have experience in areas such as design control, risk management, design change, and standards compliance.
Key Responsibilities:
* In-depth understanding of requirements and procedures governing medical device Design Control.
* Design quality leadership in resolving PIRs, CAPAs, NCEPs, and regulatory requirement changes.
* Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams to provide technical and quality systems input.
* Lead design change projects, including scoping, assessment, and implementation.
* Maintain regulatory compliance with guidance documents such as company SOP/WIs and EU/FDA/Global guidelines.
Requirements:
* NFQ Level 8 qualification in a STEM discipline.
* Min 6 years industry experience; Design Assurance experience preferable.
* Experience in areas such as design control, risk management, design change, and standards compliance.
About the Role
This role offers an excellent opportunity to develop your skills and expertise in design assurance and contribute to the success of our team.