Design Assurance Engineer

ICDS Recruitment

Galway

Design Assurance Engineer - Galway. In this role you will work aspart of the Quality function,and willprovide input to thecontract development teams in the design of highly complex medical devices. You willensure that compliance to customer and regulatory requirements is demonstrated and help to ensure successful transfer of the design to manufacturing. You will beresponsible for accurate, independent evaluation of Design History File documentation and overall Quality System compliance. Job Responsibilities: •Plan, conduct and execute design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria. •Work closely with product development engineering and the client team to establish the system design specifications and product requirements. •Perform and document all engineering studies and reports to satisfy the master verification plan. •Participate with the engineering team to establish and review the design FMEA. •Routinely provide 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. •Working with Program Managers and Process Engineers to co-ordinate and prepare sample submission packages, update and maintain the FMEA’s, Process Flow diagrams and Process Control Plans. Key Requirements for this role: •Candidates must have minimum 3-5 years'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. This job originally appeared on RecruitIreland.com.

2489 days ago