Staff Design Assurance Engineer
Our client a medical device company in Galway are currently looking to recruit a Staff Design Assurance Engineer for their site. The Senior / Staff Design Assurance Engineer provides input to our development teams in the design of highly complex medical devices. They ensure that compliance to customer and regulatory requirements is demonstrated and help to ensure successful transfer of the design to manufacturing. They are responsible for accurate, independent evaluation of Design History File documentation and overall Quality System compliance
The successful candidate will:
- 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 the application of product specific standards such as ISO 10555 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, internal and external regulatory agency audits, etc.
- Leads risk management (ISO 14971) activities for the project, including Usability Engineering requirements in compliance with IEC 62366-1 and associated guidance documents
- Leads Biocompatibility activities for the project as required, in compliance with ISO 10993 series of standards
- 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; drive 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
- Candidates must have a minimum of 5 years of relevant experience with a Bachelors 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 Staff Design Assurance Engineering role in Galway please contact Bimi Felix on 0868395533 or email firstname.lastname@example.org
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