Senior Design Assurance Engineer (Sustaining)

Sigmar Recruitment

Galway

This job is an excellent opportunity to gain exposure to a Company focused on innovative design & technologies. In this job, you will collaborate with cross functional teams to support sustaining activities within the commercialisation strategy for the entire product lifecycle. What you will do: Responsible for the design verification and design validation assessment of design changes. Lead the risk management activities in sustaining projects, design changes, complaints and CAPAs. Create and maintain design verification and validation plans, protocols, and reports for design changes. Provide sustaining support to project DA engineers on designated projects. Support the R&D team for equipment management. Co-ordinate risk management reviews for devices. Support the execution of non-clinical studies, in conjunction with R&D teams. What you will have : Level 8 Bachelor degree in Engineering, Science or related discipline. 5 years’ relevant experience in the medical device or pharmaceutical industry. Strong understanding of ISO13485, ISO14971 and FDA QSRs. Highly analytical with sound understanding of statistics, validation and physical testing. What you will receive: Competitive Salary & Comprehensive Benefits Package.

1191 days ago