QA Design Transfer Engineer I/II - Pearland, TX

Merit Medical Ireland•Pearland, TX

1d•Onsite

About The Position

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 nonconformance records (internal/external) to determine disposition, root cause, and need for corrective and preventive actions. Ensures containment (identification, segregation, and reconciliation) of nonconforming product has been performed, to prevent unintended use. Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of quality policy, quality objectives, audit results, analysis of data, risk management, etc. Evaluates the work environment in which product is manufactured, and ensures it is adequately controlled and monitored, with sufficient personnel and safety production controls. Performs a variety of other tasks and related work, as required.

Requirements

Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field.
Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards.
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.

Nice To Haves

Medical device experience or equivalent experience in a regulated industry.
Experience with Minitab and Oracle.
Passed ASQ Certified Quality Engineering exam.

Responsibilities

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.
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 nonconformance records (internal/external) to determine disposition, root cause, and need for corrective and preventive actions.
Ensures containment (identification, segregation, and reconciliation) of nonconforming product has been performed, to prevent unintended use.
Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of quality policy, quality objectives, audit results, analysis of data, risk management, etc.
Evaluates the work environment in which product is manufactured, and ensures it is adequately controlled and monitored, with sufficient personnel and safety production controls.
Performs a variety of other tasks and related work, as required.