Senior QA Design Transfer Engineer I

Merit Medical; Tijuana; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Interpersonal Skills

Organization

Written and Verbal Communication

Teamwork

Conflict Resolution

Negotiation

Problem Solving

Decision Making

Educación

Bachelor's Degree in Engineering or related field

Herramientas

Minitab

JMP

Oracle

Descripción del empleo

ESSENTIAL FUNCTIONS PERFORMED

• Participates in design and development activities assuring the design requirements are appropriately transferred into manufacturing. Guides the design team as subject matter expert of Design Control from Design Inputs through Design Outputs, Process Validation, Test Method Validation and Device Master Record creation.


• Responsible for coordinating 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.


• 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.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

• Lifting -- Not to exceed 50 lbs. – local practice may apply.


• Writing


• Sitting


• Standing


• Bending


• Visual acuity


• Color perception


• Depth perception


• Reading


• Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field.


• A minimum of eight (8) years of engineering experience.


• Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards.


• Advanced Engligh level


• TMV, MVP and validations experience (must)


• Working knowledge of statistical methodologies, quality control and manufacturing tools such as problem solving, root cause investigation, applied statistics, lean manufacturing, Six Sigma, etc., and project management experience.


• Knowledge of applicable regulatory agency regulations.


• Demonstrated computer skills, preferably spreadsheets, word processing, database, and other applicable software programs.

PREFERRED QUALIFICATIONS

• Medical device experience or equivalent experience in a regulated industry.


• Experience with Minitab or JMP, Oracle.


• Passed ASQ Certified Quality Engineering exam.

COMPETENCIES

• Interpersonal Skills


• Organization


• Written and Verbal Communication


• Teamwork


• Conflict Resolution


• Negotiation


• Problem Solving


• Decision Making

COMMENTS

Infectious Control Risk Category II:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.