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TITLE

 

Manufacturing Engineer

COMPANY

 

Silk Road Medical

LOCATION

 

Sunnyvale, CA, US

Description

The Manufacturing Engineer is responsible for supporting all aspects of Manufacturing Operations at Silk Road Medical.
Maintain quality standards in and around manufacturing areas, ensuring a safe work environment for all personnel and helps to develop a culture of accountability, continuous improvement, and collaboration.

MAJOR DUTIES AND RESPONSIBILITIES:
• Write, review, and improve manufacturing procedures and forms in compliance with the quality system.
• Support departmental responsibilities associated with training and qualifying manufacturing assemblers.
• Create and revise drawings for components, subassemblies, and tooling.
• Support improvement activities for new and existing manufacturing processes.
• Perform validations (IQ/OQ/PQ) for any updates to the manufacturing equipment and processes.
• Perform investigation and material disposition for Non-Conforming Material Reports (NCMRs).
• Perform root cause investigations and develop Corrective Action and Preventative Action (CAPA) plans.
• Respond to manufacturing emergencies and resolve Production line down(s).
• Maintain safety, quality, and GMP standards across all manufacturing areas.


REQUIREMENTS / QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor’s degree in Engineering: Mechanical, Industrial, Manufacturing and Process disciplines desired.
• 0 to 2 years of prior relevant experience or equivalent combination of education and experience.
• Prior experience with catheter manufacturing desired.
• Ability to solve practical problems and deal with a variety of variables in pressure situations.
• Effective verbal and written communication skills.
• Excellent attention to detail, flexible, and adaptable to change.
• The ideal candidate must be self-motivated, highly organized, and resourceful in solving issues as they arise. In addition, possess a well-developed team orientation with critical thinking and problem solving/analytical skills.

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