Our client, a growing manufacturing company requires a DA Engineer for a contract role in Galway. This role will involve providing input to 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
- 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.
- Performs and documents all engineering studies and reports to satisfy 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.
- Support various QA/RA activities including quality management, system reviews, audits, etc.
- 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
- Root cause analysis and implementation of corrective action for process related concerns.
- Provide QA direction for project including receiving and on line inspections.
- Interact with customer on requirements for the project from a quality control perspective.
- Be the quality representative for assign projects in conjunction to DA activities.
- Working with Program Managers and Process Engineers to co-ordinate and prepare sample submission packages, updates and maintains the FMEA?s, Process Flow diagrams and Process Control Plans.
Education, Experience and Skills
- 3-5 years of relevant experience with a Bachelor?s degree or higher in Engineering, or a related discipline.
- Work independently and as a member of a cross-functional team, to multi-task and do what it. Will be working on highly visible projects in high-pressure situations.
- 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 Cliona O?Malley on 091730022 / firstname.lastname@example.org
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