Senior Design Assurance Engineer
Welcome to Medtronic, a global leader in medical technology and healthcare solutions. We are currently seeking a highly skilled and experienced Senior Design Assurance Engineer to join our dynamic team. As a Senior Design Assurance Engineer, you will play a pivotal role in ensuring the quality and safety of our products, as well as driving continuous improvement in our design processes.To excel in this role, you will need to have a strong background in design assurance and quality engineering, as well as a passion for innovation and attention to detail. If you are a creative problem-solver with a drive for excellence, we invite you to join our mission of improving patient outcomes and transforming healthcare.
- Oversee the design assurance process for all new and existing products, ensuring compliance with regulatory requirements and internal quality standards.
- Lead design reviews and risk assessments to identify potential issues and implement appropriate corrective actions.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure timely and successful product launches.
- Develop and maintain design control documentation, including design inputs, outputs, verification and validation protocols, and design history files.
- Monitor and analyze product performance data, identifying trends and opportunities for improvement.
- Conduct audits and assessments of suppliers and internal processes to ensure compliance with quality standards.
- Act as a subject matter expert on design assurance and quality engineering, providing guidance and training to other team members.
- Stay current on industry trends and regulations related to medical device design and quality, and make recommendations for process improvements.
- Drive continuous improvement efforts through the implementation of best practices and innovative solutions.
- Foster a culture of quality and excellence within the design assurance team and the wider organization.
Minimum Of 7 Years Experience In Medical Device Design Assurance, Preferably In Class Iii Devices.
In-Depth Knowledge Of Fda Regulations And International Standards (Iso 13485, Iso 14971) For Medical Device Design And Development.
Strong Understanding Of Risk Management Principles And The Ability To Lead Risk Assessments And Implement Risk Mitigation Strategies.
Experience With Product Verification And Validation Activities, Including Test Method Development, Protocol Writing, And Report Generation.
Proven Track Record Of Collaborating With Cross-Functional Teams, Including R&D, Quality, And Regulatory, To Ensure Successful Product Development And Launch.
Project Management
Quality Management
statistical analysis
Root Cause Analysis
Design verification
Process validation
Compliance Management
Risk assessment
Design Control
Regulatory Requirements
Failure Mode And Effects Analysis (
Communication
Conflict Resolution
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Senior Design Assurance Engineer in Galway, Ireland is approximately €60,000-€80,000 per year. However, this can vary depending on factors such as level of experience, specific industry, and company size.
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Medtronic plc is the world's largest medical device company that generates the majority of its sales and profits from the US healthcare system and is headquartered on the island of Ireland.
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