Our client, a major multinational here in Galway, is seeking a Design Assurance Engineer II on a permanent basis to join their growing team.
The Role:
Fulfill the quality assurance responsibilities of company product development and related PTP engineering activities, including:
* Creating and maintaining a culture of commitment to improving patient safety, customer satisfaction, and product quality.
* Assuring compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry.
* Promoting and effecting compliance to quality, business, and health & safety systems and market/legal regulations.
* Analyzing, reducing, and managing risks associated with the design, use, and manufacture of devices.
* Selecting appropriate techniques for problem solving and making solid and consistent engineering and quality recommendations.
* Providing expertise in product development systems to project teams.
Responsibilities:
General:
* Interface with R&D, Regulatory Affairs, Clinical, Marketing, Process Development, and Manufacturing functions in a project team environment.
* Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance of product development activities to internal and external requirements.
* Monitor the release and updates of quality policies to ensure compliance with Product Development needs and communicate this information to the Product Development Group.
* Continually seek to drive improvements in product and process quality.
* Implement, maintain, and update procedures that ensure that R&D documentation constantly meets Product Development Process and Design Control requirements.
* Provide quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols, and reports for new development projects as well as design/process changes to existing product lines.
* Support internal and external audits.
Technical:
* Provide regulatory compliance, risk management, design control, and quality systems expertise to the team.
* Summarize, analyze, draw conclusions, and make appropriate decisions from test results or other process-related findings.
* Be fully conversant with verification/validation techniques, risk management, statistical techniques, and associated regulatory requirements.
* Build quality into all aspects of work by maintaining compliance with all quality requirements.
* Keep up to date on all ISO/EN/FDA/MDD and other Product Development related regulatory requirements and relay this information to the Product Development group.
* Be a good team member, committed to the project's success and fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
* Cardiac Valve Knowledge/Understanding:
o Knowledge/understanding of EN ISO 5840-1 & -3
o Material knowledge of nitinol
o Material knowledge of animal origin (bovine or porcine)
o Valve testing
* Familiar with Product Functional Testing including aging studies.
* Knowledge of the NCEP process.
Requirements:
* Level 8 Bachelor's Degree (240 credits) in STEM (Quality, Science, or relevant discipline).
* 3+ years of experience in a similar role.
For more information and a confidential discussion on the role, please contact Michelle Mc Inerney.
Skills:
Design Assurance Engineer
#J-18808-Ljbffr