Senior QA Design Transfer Engineer I - Pearland, TX

Work Shift: DAY At Merit Medical, our mission is to create innovative medical devices that improve lives. ESSENTIAL FUNCTIONS PERFORMED Participates in design and development activities ensuring 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, including 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 for assigned product line(s) and processes and production control(s). Conducts complete and conceptually related studies to approach technical problems that 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 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 quality policy, quality objectives, audit results, data analysis, risk management, etc. Evaluates the work environment in which product is manufactured, ensuring 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 the effectiveness of corrective/preventive actions. Performs a variety of other tasks and related work as required. 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. 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 Risk Category 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. Benefits Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights Medical/Dental & Other Insurances (eligible the first of month after 30 days) Low Cost Onsite Medical Clinic Two (2) Onsite Cafeterias Employee Garden | Gardening Classes 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays 401K | Health Savings Account Military Veterans Military Veterans are encouraged to Apply. #J-18808-Ljbffr 300 Merit Medical Ireland, Limited