Senior Design Assurance Engineer required by a market leading Medical Device multinational based in Galway to help ensure successful transfer of design to manufacturing.
- Plans, conducts and executes design assurance activities.
- Works closely with product development engineering and the client team to establish the system design specifications and product requirements.
- Works closely with design, development, quality, regulatory, and the client team to establish and document the master verification plan.
- Performs and documents all engineering studies and reports to satisfy the master verification plan.
- Plans, coordinates and executes design verification testing to directly support the master verification plan.
- Participates with the engineering team to establish and review the design FMEA.
- Provides design assurance guidance and direction to engineers.
- Possesses a comprehensive understanding of the application of product-specific standards.
- Support various QA/RA activities.
- Leads risk management (ISO 14971) activities for the project.
- Leads Biocompatibility activities for the project.
- Evaluation of new products, assuring the safety and efficacy of the devices.
- Design verification and shelf life protocols/reports review and approval.
- Lead and own CAPAs as required, drive root cause investigations and problem-solving efforts for quality issues.
- Clearly present information to Regulatory Affairs to minimize Regulatory Agency questions.
- Support customer complaint analysis and post market surveillance activities.
- Generate and approve change requests.
- BSc. or higher in Engineering, or a related discipline.
- 5 years relevant experience.
- Must be able to work independently and as a member of a cross-functional team.
- Ability to work on highly visible projects in high-pressure situations.
- Ability to communicate appropriately with different teams.
- Some travel required.
- Must be authorised to work in Ireland.
Please contact Emer Moore to discuss in confidence