Senior Design Assurance Engineer

Careerwise Recruitment

Galway

A Senior Design Assurance Engineer is required by CareerWise Recruitment for our Galway based client. The Senior Design Assurance Engineer provides input to the development teams (R&D) in the design of highly complex Medical Devices. THE ROLE: * 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 Clear present information to Regulatory Affairs to minimize Regulatory Agency questions Support customer complaint analysis and post market surveillance activities Generate and approve change requests. REQUIREMENTS: * 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. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. This job originally appeared on RecruitIreland.com.

2161 days ago