Design quality engineer

Descripción general

GENERAL POSITION SUMMARY:
The Design Quality Engineer is responsible to ensure the function of Quality Assurance during the stages of design and development of disposable products. The DQE, shall adhere to the highest possible professional standards while quality and integrity are maintained in the development and sustaining engineering associated with disposable medical products. The incumbent must write precise technical documentation and reports and maintain highly detailed files, records and entries in personal log book(s). Responsible for developing products within the framework of (including but not limited to) ISO 13485, ANSI, AAMI and GMP standards. Responsible for defining product features with marketing group, establishing budgets, task objectives, schedules, and ensuring the most efficient use of company resources to meet these goals. Evaluator for new component supplier and responsible to define the key quality requirements needed in a component basis.
CORE RESPONSIBILITIES:
•Ensure that the design for manufacturing features are properly applied according to Quality standards.
•Design, develop, document, verify and validate Design Quality and related assembly equipment.
•Maintain all project-related documentation, including writing tests and assembly procedures, validation protocols and initiating Engineering Change Notices as needed.
•Create, test and implement sounded test methods validations as required by the new products and processes.
•Ensure proper characterization of design risk during the DFMEA creation and that corresponding mitigation controls are included in the design phase.
•Act as a consultant to other departments relative to design quality compliance on matters of: design, plastics, assembly methods, sterilization and other related technologies.
•Document and follow-up on current design-sustaining problems.
•Investigate and disposition/document field failures and customer complaints as needed.
•Provide Design

Requisitos para aplicar

EDUCATION AND/OR EXPERIENCE:
Bachelor’s degree (B.A.) in mechanical engineering or related engineering discipline; plus five years of work experience in design and manufacture of disposable medical products fabricated from extruded and injection molded engineering plastics.
REQUIRED QUALIFICATIONS:
•Ability to be innovative in the design and development of medical Design Quality.
•Through statistical knowledge.
•Project management skills.
•Thorough knowledge of plastic product manufacturing including manual and automated assembly methods.
•Must be able to work in a team environment as well as to independently manage in all technical aspects of Design Quality .
•Ability to analyze and solve difficult technical problems.
•Strong communication skills in person, phone, via email.
•Knowledge of Word processing spreadsheets, scheduling, database and various project management software.
•Ability to plan, develop, and oversee the design and fabrication of automated and manual disposable product assembly systems.
•Able to succeed in highly regulated compliance oriented environment while still providing service excellence