L373 - R&D Project Engineer - Medical Devices- Foranea

L373 - R&D Project Engineer - Medical Devices- Foranea

20 feb
|
Ab Recruiting & Staffing
|
Nuevo Laredo

20 feb

Ab Recruiting & Staffing

Nuevo Laredo

R&D; Project Engineer - Medical Devices- Foranea



R&D; Project Engineer - Medical Devices- Foranea



Descripción y detalle de las actividades

Company located in Nuevo Laredo, Tamps. is searching for a R&D; Project Engineer for Medical Devices, responsibilities include: Planning and execution of product performance testing in accordance to design control procedures and to meet EU Medical Device Regulation (MDR) requirements and deadlines. Transition of Technical Files from Medical Device Directive (MDD) to Medical Device Regulation (MDR). Products affected include all EU regulatory classifications, Class I, II, and III.

Reviews of the Technical Files and Design Dossiers in preparation for new MDR regulations are being planned and executed in a timely manner. Generate test protocols, analyze test data, and generate written reports. Plan and lead the verification and validation activities for manufactured or purchased new/replacement components. Guide technical resources in the development/improvement of products and processes, optimize by utilizing Design Of Experiment (DOE), assist in their implementation with appropriate controls and metrics. Interface with suppliers to obtain information required to update Technical Files and DHF documentation. Interface with purchasing and marketing to develop supplier agreements for components and/or new products. Direct the efforts of draftsmen, technicians, tradesmen, and lab personnel in the development of test fixtures, equipment, test procedures and documentation.

Experiencia y requisitos

EDUCATION / EXPERIENCE REQUIREMENTS:

• B.S. Degree in Science or related engineering, PMP certification preferred.

• Bilingual English - Spanish

• Minimum 3+ years’ previous working experience in medical device regulated environment, manufacturing and assembly, disposables manufacturing processes, plastics, automation.

• Experience in Medical devices, Class I, II, III,

• Extensive knowledge of MDD to MDR, applicable to the design and development of medical devices.

• Experience by utilizing tools such as Design of Experiment (DOE).

• Knowledge of international requirements, quality management systems.

• Proficient in Microsoft Office – PC, Word, Excel, PowerPoint.

• Leadership capabilities and good interpersonal skills to work in a team environment and the ability to lead others.

• Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.

• Excellent Organizational and Planning skills, problem-solving, collaboration and project management skills.

El anuncio original lo puedes encontrar en Kit Empleo:
https://www.kitempleo.com.mx/empleo/16285595/l373-rd-project-engineer-medical-devices-foranea-nuevo-laredo/?utm_source=html

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