Senior Design Assurance Engineer

CREGG; Dublin; Hybrid; EUR 60,000 - 80,000; Full time

Job summary

A leading Medical Device company in Dublin is seeking a Senior Design Assurance Engineer. This hybrid role involves supporting project compliance throughout the product lifecycle and requires expertise in quality assurance and regulatory standards. The ideal candidate should have a Level 8 qualification in Engineering or Science and at least 4 years of experience in a Quality role, preferably within the Medical Device industry.

Qualifications

• 4+ years of relevant industry experience in a Quality role.
• Knowledge of Medical Device industry preferred.

Responsibilities

• Support sustaining projects from a Design Assurance perspective.
• Generate Design Verification protocols for regulatory submissions.
• Collaborate with engineering and manufacturing functions.

Skills

Regulatory compliance knowledge

Quality Assurance

Technical writing

Problem-solving

Communication skills

Education

Level 8 qualification in Engineering/Science

Job description

Overview

Senior Design Assurance Engineer – Permanent – Hybrid. This is a fantastic opportunity to join a world leading Medical Device company in Co. Galway working in the exciting role as a Senior Design Assurance Engineer, on the latest products and technologies with great career progression opportunities.

Responsibilities

• Support sustaining commercial projects from a Design Assurance perspective. You will be directly involved in making sure our products are maintained through the full product lifecycle and that these products comply with global standards.
• Support the introduction/implementation of product/process/materials changes to the manufacturing operation. You will assess the patient risk appropriately for these design changes. You will provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Mfg. Engineering.
• Responsible for generation of Design Verification protocols & will participate in the compilation of design verification and shelf life data for regulatory submissions to support design change approval.
• Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions.
• Contribute to establishing strong working cross functional relationships across the organization and with partners within a complex technical environment.
• As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, and commercialization activities. You will generate and approve change requests. Lead investigation analysis and timely completion of same.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Dynamic team player who can work effectively and proactively on cross-functional teams
• Good communicator and fluent in English, both in writing and speaking.
• Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.
• Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures
• Strong problem solving and analytical skills
• Strong problem-solving skills with the ability to identify root causes and implement corrective actions.
• Strong technical writing ability.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Requirements

• Level 8 qualification in relevant discipline – Engineering/Science or other.
• 4+ years of relevant industry experience in a Quality role – Quality Engineering/Design Assurance/R&D
• Industry knowledge and experience in Medical Device preferred but not essential.