QA Design Transfer Engineer I/II (Tijuana)

QA Design Transfer Engineer I/II (Tijuana)

12 ago
|
Merit Medical Systems
|
Tijuana

12 ago

Merit Medical Systems

Tijuana

Work Shift: DAY Work Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
ESSENTIAL FUNCTIONS PERFORMED
- Participates in design and development activities assuring the design outputs are appropriately transferred into manufacturing
- Guides the design team through Process Validation, Test Method Validation and Device Master Record creation
- Responsible for coordinating process risk analysis/management activities. This may include leading risk management analysis meetings, documenting results, following up to ensure risk mitigation and facilitating improvements
- Reviews, approves, and generates Engineering Change Notifications (ECNs) to update or generate verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s)




- Conducts complete and conceptually related studies to approach technical problems, where the problems are difficult to define, require unconventional or novel approaches, and require sophisticated research techniques
- Performs technical work where available guides and precedents contain critical gaps, are only partially related to the problem, or may be largely lacking due to the novel character of the project
- Contributes techniques which are of material significance to solve specific problems and drive continuous improvement
- Keeps abreast of new scientific methods, standards, regulations, and developments affecting the organization for the purpose of recommending changes to processes, systems or designs warranted by such developments
- May plan, organize, and mentor the work of engineers or technicians on various engineering projects and quality system compliance issues
- Reviews no

📌 QA Design Transfer Engineer I/II (Tijuana)
🏢 Merit Medical Systems
📍 Tijuana

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