Senior Quality Assurance Design Transfer Engineer I

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.

SUMMARY OF DUTIES

Provides quality engineering support for products and processes while completing projects in broad areas of assignment supporting design transfer activities. Finalize requirements associated with product development, design controls, and product risk management. Ensures that the products are designed, tested, and manufactured in compliance with all applicable agency/internal quality requirements and optimizing quality systems and documentation.

DUTIES & RESPONSIBILITIES

• 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.
• 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 engineers or technicians on various engineering projects and quality system compliance issues.
• Mentors and evaluates competency of Quality Auditors, Design Assurance/Quality Engineers, and technicians, by providing training or other actions required to satisfy quality objectives.
• 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.
• May support Internal Audit and supplier audit activities, performing audits, writing audit reports, and following up on effectiveness of corrective/preventative actions.
• Performs a variety of other tasks and related work, as required.

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field.
• Language: English (Fluency) and French (Fluency)
• 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.
• 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.
• Expertise in design and development of Test Method Validations (TMV).
• Expertise in creating and conducting Master Validation Plans (MVP).
• Experience in conducting Validations (IQ, OQ, PQ).
• 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.

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Key Benefits

• Attractive Salary package

• Defined Contribution Pension Plan

• Health Insurance Cover

• Life assurance

• Health & Wellbeing Events Calendar

• Excellent career progression opportunities

• Recognition scheme

• Free Parking

• Educational assistance

• Internal training courses

• Quality Subsidised Canteens & Barista Service

• Active Sports and Social Club

We are Global

Merit Medical Galway commenced with 22 employees in 1993. Since then Merit has enjoyed year on year revenue growth and developed its workforce to over 900 employees. Headquartered in Salt Lake City, Utah, Merit maintains a diverse, multi-campus manufacturing footprint in Europe, North America, South America, Asia and Australia with a global distribution.

Medtech Company of the Year Winner

Merit Medical Galway are proud winners of the Medtech Company of the Year Award, a prestigious award recognizing those who are exceling in the MedTech industry.

People Development

At Merit Medical Galway almost 60% of all roles are filled by internal employees! We focus on encouraging, believing in and providing a platform for you to progress your career!

Culture

A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture. Diversity & Inclusion is evident here with an 50/50 ratio of male and female employees as well as 30 nationalities onsite! We value every employee as an individual.

To see more on our culture, go to www.merit.com/careers.