Our client a medical device company in Galway requires an experienced Senior DA engineer to join their team. The Senior DA Engineer will ensure that compliance to customer and regulatory requirements is demonstrated and help to ensure successful transfer of the design to manufacturing.
- Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria.
- 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 in conformance with the system design specification and sound testing principles.
- 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.
- Routinely provides design assurance guidance and direction to engineers and/or technicians for the duration of a project assignment.
- Possesses a comprehensive understanding of ISO10555 principles, design FMEA practices, and any industry standards to ensure products satisfy all ISO 13485 requirements.
- Support various QA/RA activities including quality management, system reviews, audits, etc.
- Support risk management activities
- Evaluation of new products, assuring the safety and efficacy of the devices
- Design verification and shelf life protocols / reports review.
- Root cause investigations; drive problem solving efforts for quality issues
- Support customer complaint analysis and post market surveillance activities
- Generate and approve change requests
- Candidates must have 3-5 years of relevant experience with a Bachelor's degree or higher in Engineering, or a related discipline.
- Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations.
- Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, vendors and partners, and customers.
- Must be able to travel occasionally to meet with customers / project teams
For further information on this Design Assurance Engineer role in Galway please contact BImi Felix on 091730022 / email@example.com
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