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Overview
We are seeking a highly skilled Senior Design Assurance Engineer to join an innovative and rapidly growing medical device organization. The company is at the forefront of advancing vascular intervention solutions, driven by a commitment to excellence and a strong patient-centric ethos. Our collaborative culture fosters professional and personal development, while consistently adhering to the highest standards of integrity and quality.
Role Summary
Reporting to the Director of Design Assurance, you will work closely with our development teams to enhance a diverse portfolio of new products, primarily focused on the treatment of various peripheral arterial conditions. This role offers a unique opportunity to contribute to cutting-edge projects and work in a supportive, dynamic environment at our state-of-the-art facility.
Key Responsibilities
Quality System & Regulatory Compliance:
* Ensure adherence to company quality policies and systems in accordance with Medical Device Regulation 2017/745, Medical Device Directive 93/42/EEC, FDA Quality System Regulations 21 CFR Part 820, FDA GLP Regulation 21 CFR 58, ISO 13485, ISO 14971, and the Japanese Ministerial Ordinance # 169.
Process Development:
* Contribute to the evolution of the design control, risk management, and labeling/packaging systems.
Design Assurance Support:
* Provide expert guidance on design assurance for R&D project teams, supporting both new developments and design changes to meet updated regulatory requirements.
Regulatory Integration:
* Ensure product developments address all regulatory requirements, and lead efforts in design specification, design input/output documentation, and risk management.
Human Factors & Usability Engineering:
* Oversee Human Factors and Usability Engineering activities, maintaining a comprehensive Usability Engineering File for all products.
Testing & Validation:
* Develop and validate test methods to support various development programs, and manage the creation and maintenance of design verification/validation plans, protocols, and reports.
Design Documentation:
* Establish and maintain the Design History File (DHF) and other key documents, supporting comprehensive and accurate design reviews and non-clinical studies.
Support in Equipment Management:
* Provide design assurance support for R&D in equipment management and validation, ensuring labeling and packaging meet all regulatory standards and are implemented in a timely manner.
Standards Gap Analysis:
* Execute and review gap analyses against standards and related documents, assessing impacts to product documentation.
* Mentor and coach colleagues and junior team members to promote continuous learning and development within the team.
Required Qualifications
* Education:
* A Bachelor's degree in Engineering, Science, or a related field is required.
* Experience:
* Minimum of five years’ relevant experience in the medical device industry, ideally with exposure to stent or Class III device design assurance.
* Demonstrated knowledge of ISO 13485, ISO 14971, and FDA QSRs.
* Proficiency in risk management, statistics, validation, and physical testing methodologies.
* Strong communication and organizational skills, with the ability to produce clear and detailed reports.
* Competitive salary and performance-based bonus structure.
* Pension scheme with generous employer contributions.
* Private medical insurance for you and your immediate family, paid sick leave, and group life cover.
* Generous annual leave starting at 23 days (plus bank holidays), increasing with tenure.
* A vibrant sports and social committee with regular events, flexible start/finish times, and a hybrid working model.
* Opportunities for further education, training, and ongoing professional development.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing and Research Services
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