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
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