R&d engineer (medical devices designing)

Descripción general

The Disposable Products Engineer is responsible to ensure the highest possible professional standards, quality and integrity are maintained in the development and sustaining engineering associated with disposable medical products. Responsible for the final Quality Control of all drawings and revision changes to insure they are correct and complete. 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. Core Responsibilities: •Act as project manager for assigned MMDG disposable products and assume all engineering responsibilities for those products •Design, develop, document, verify and validate disposable products and related assembly equipment. •Maintain all project-related documentation, including writing tests and assembly procedures, validation protocols and initiating Engineering Change Notices. •Solve problems and implement improvements in existing designs. •Act as a consultant to other engineering departments relative to design, plastics, assembly methods, sterilization and other related technologies. •Document and follow-up on current production problems. •Investigate and disposition/document field failures and customer complaints. •Provide engineering assistance to vendors in solving production problems involving disposable product lines.

Requisitos para aplicar

Education and/or Experience: Minimum requirements: Engineering degree (Mechanic or Industrial) and 5 years of experience in the medical device industry in engineering roles. Master’s degree is a plus. Desirable education: knowledgeable in Minitab, MS Project,SolidWorks, Green/Yellow belt is a plus.


Required Qualifications:

•Ability to be innovative in the design and development of medical disposable products.
•Project management skills.
•Thorough knowledge of automated assembly methods.
•Must be able to work in a team environment as well as to independently manage in all technical aspects of disposable products.
•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.