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.