Cache of job #13833621

Job Title

Design Assurance Engineer

Employer

CPL

Location

Galway

Description

Excellent opportunity to join a team of senior design engineers. You will be working on innovative sensor based devices. You will also have responsibility of all aspects of design control.You will also be involved in inputs -verification – validation – working with physicians. Main background required: Essential Experience: Design Control. Risk management / ISO14971. Familiar with product specific requirements – ISO555 PART 1 (standard for intravascular catheters. Main Experience. Candidates must have 3-5 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. Job Responsibilities: 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. Please contact Fiona KEane at 091 507 502 or 086 027 9952 or email fiona.m.keane@cpl.ie. This job originally appeared on RecruitIreland.com.

Date Added

2317 days ago

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