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Objective:

Responsible for the design and development planning for new designs of products and processes and the change of existing products and processes, including design verification, validation and clinical evaluation.

Responsibilities and Essential Functions:

• Document design inputs to addresses 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 the proper procedures.
• Perform design validation in accordance with the proper procedures.
• Develop manufacturing processes for the 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.

Authorities:

• Reject design changes and new product implementation that has not followed the design control process.
• Reject designs in design reviews and or design validations

Work Environment:

This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration or other workplace hazards controlled within compliance of current safety and health standards.

Qualifications:

• Degree in engineering or related field and 3-5 years of relevant work experience
• Experience working in the medical device field preferred.
• Must be able to read, write and understand English.