JOM/AUGC-571333

Design Assurance (DA) Engineer

Location Galway

Area Medical Devices

An exciting Design Assurance Engineer role is now available in a progressive Medical Device company in Galway, excellent package and benefits including 4 day working week with some opportunity to work from home.

Responsibilities

• Understand clinical application of the product, utilizes clinical knowledge while supporting development of design inputs and clinically relevant test methodologies.
• Develop and execute test method validations.
• Develop design verification, design validation, and usability plans, protocols, and reports.
• Leads execution of risk management activities for new product/technology development projects.
• Supports post market activities including but not limited to- generating field assessment and post market surveillance reports.
• Promotes ongoing compliance to the applicable regulatory standards by performing standards gap assessments and supports mitigation activities.
• Support design transfer activities including process validation and material qualifications.
• Support external and internal audits and provide Design Assurance representation for nonconformance reports, complaints, internal and external audit findings and CAPAs

• An Engineering or Quality Assurance Degree or equivalent experience.
• A minimum of 3 years post qualification experience as a Design Assurance Engineer within a Medical Device or regulated environment.

• Understand regulatory requirements for the product, supports pre-submissions, submissions, and questions from the regulatory agencies.
• Strong technical writing and verbal communication skills.
• A good team player who works effectively on their own and with peers from cross functional areas.
• Takes an analytical approach to problem solving with capacity to make sound judgements