Medical Device NPD Engineer — Design & Validation

Ambu; Ciudad Juárez; Presencial; MXN 350.000 - 550.000; Jornada completa

Descripción de la vacante

Ambu is seeking a design and development planning professional for its operations in Ciudad Juárez. The role focuses on planning new product designs, changes to existing designs, and ensuring design verification, validation and clinical evaluation are conducted in line with quality systems.

The candidate should hold an engineering degree with 3–5 years of relevant medical device experience and be able to read, write, and understand English.

Formación

• Must have engineering degree and 3–5 years of relevant work experience.
• Experience in the medical device field is preferred.
• Must be able to read, write and understand English.

Responsabilidades

• Document design inputs to address the intended use of the product.
• Design new products and changes.
• Follow procedures for design changes and new products.
• Evaluate the conformance of new products and changes in accordance with the specified design input and document the conformance in a design output.
• Perform design Reviews.
• Perform design verification in accordance with proper procedures.
• Perform design validation in accordance with proper procedures.
• Develop manufacturing processes for new or changed designs.
• Design for manufacturing
• Improve existing manufacturing processes.
• Cross functional approval of design verification and validation activities for independent projects.
• Write and execute protocols for testing within the design control process.
• Develops processes for the manufacturing of new products and changes of existing products.
• Responsible for creating Design History Files.
• Responsible for understanding all applicable procedures and product requirements.
• Work as part of a cross functional team and apply existing competencies.
• Contribute to achieving the goals of Ambu USNV.
• Communicate regularly with other members of the department.
• Ensure cross functional communication is occurring to secure implementation of new designs and changes.
• Secure creative workshops to achieve the best designs and solutions.
• Master the SCRUM process.
• All other duties as assigned.

Conocimientos

English proficiency

Educación

Engineering degree

Descripción del empleo

Ambu is seeking a design and development planning professional for its operations in Ciudad Juárez. The role focuses on planning new product designs, changes to existing designs, and ensuring design verification, validation and clinical evaluation are conducted in line with quality systems.

The candidate should hold an engineering degree with 3–5 years of relevant medical device experience and be able to read, write, and understand English.