Senior QA Design Transfer & Validation Engineer

Merit Medical; Tijuana; On-site; MXN 900,000 - 1,300,000; Full time

Job summary

Merit Medical in Mexico is seeking an experienced Engineer to guide Design Control from Design Inputs through Design Outputs, Process Validation and Device Master Record creation. You will coordinate risk analysis/management activities and lead risk mitigation efforts for medical devices.

Responsibilities include reviewing ECNs, updating verification and validation methods, and solving complex technical problems while staying current with regulatory standards and industry best practices.

Qualifications

• Bachelor's Degree in Engineering or related field.
• 8 years of engineering experience.
• Knowledge of 21 CFR 820, ISO 13485, ISO14791 and other medical device standards.
• Advanced English level.
• TMV, MVP and validations experience (must).
• Statistical methodologies, quality control and manufacturing tools (e.g., lean manufacturing, Six Sigma).
• Knowledge of regulatory agency regulations.
• Computer skills: spreadsheets, word processing, databases.

Responsibilities

• Participates in design and development activities ensuring design requirements transfer into manufacturing; guides the design team on Design Control through Design Inputs to Design Outputs, Process Validation, Test Method Validation and Device Master Record creation.
• Coordinates risk analysis/management activities; leads risk management meetings, documents results, follows up to ensure mitigations.
• Reviews, approves, and generates Engineering Change Notifications (ECNs) to update verification, validation, monitoring and inspection methods and test protocols for assigned product lines and processes.
• Conducts complete and conceptually related studies to address difficult technical problems with novel approaches.
• Performs technical work where guides are insufficient or partially related to the problem, especially for novel projects.
• Keeps abreast of new scientific methods, standards, regulations and developments to recommend changes to processes, systems or designs as warranted.

Skills

Interpersonal Skills

Organization

Written and Verbal Communication

Teamwork

Conflict Resolution

Negotiation

Problem Solving

Decision Making

Education

Bachelor's Degree in Engineering or related field

Tools

Minitab

JMP

Oracle

Job description

Merit Medical in Mexico is seeking an experienced Engineer to guide Design Control from Design Inputs through Design Outputs, Process Validation and Device Master Record creation. You will coordinate risk analysis/management activities and lead risk mitigation efforts for medical devices.

Responsibilities include reviewing ECNs, updating verification and validation methods, and solving complex technical problems while staying current with regulatory standards and industry best practices.