Senior Manufacturing Engineer

San Francisco, CA, US • Posted 1 day ago • Updated 1 day ago

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Job Details

Skills

Analytical Skill
Collaboration
Continuous Improvement
Critical Thinking
Decision-making
Documentation
IQ
ISO 13485

Summary

We are looking for Senior Manufacturing Engineer for our client in San Francisco, CA

Job Title: Senior Manufacturing Engineer

Job Location: San Francisco, CA

Job Type: Contract

Job Description:

Pay Range: $65hr - $70hr

The Sr Manufacturing Engineer is responsible for supporting and improving manufacturing processes within a regulated medical device environment.
This role focuses on process validation, new product transfer, continuous improvement, tooling development, and cross-functional collaboration.
The ideal candidate will have strong analytical skills and experience working in ISO 13485 and FDA regulated environments.

Requirement/Must Have:

Bachelor s degree in Engineering or a related field.
Minimum 5+ years of experience in medical device manufacturing or a similar regulated industry.
Experience with continuous process improvement and process validations.
Experience working in ISO 13485 and FDA regulated environments.
Strong analytical, creative, and critical thinking skills.
Ability to work in a fast-paced, cross-functional environment.
Ability to travel within the United States as required.

Experience:

Experience supporting new and existing manufacturing processes.
Experience leading new product transfer from R&D to manufacturing.
Experience drafting and executing product, equipment, and process validations including IQ/OQ/PQ.
Experience managing prototype and pilot production builds.
Experience performing root cause analysis and implementing corrective actions.
Experience developing and reviewing manufacturing and engineering documentation.
Experience working with tooling, fixtures, PLM systems, and QMS processes.

Responsibilities:

Support new and existing manufacturing processes, product changes, enhancements, tooling, and fixtures.
Support prototype and pilot production activities, facilities planning, and process development.
Interface with cross-functional departments to resolve production issues.
Conduct investigation and testing of product processes.
Lead manufacturing efforts associated with new product transfers.
Draft and execute validations for products, equipment, and processes.
Manage prototype and pilot builds including operator training and coordination with production planning.
Analyze data to improve and ensure robust and repeatable manufacturing processes.
Collaborate with internal departments and external services to implement process modifications and resolve issues.
Review and develop manufacturing and engineering documentation.
Provide solutions to complex issues related to process, equipment, materials, supply chain, documentation, validation, and QMS processes.
Perform root cause analysis and implement process improvements to increase manufacturing yield.
Support design and development of tooling and fixtures for new and existing products.
Identify and implement new technologies to improve manufacturing processes and equipment design.
Establish and maintain monitoring systems for key manufacturing process metrics.
Present analytical data clearly to support decision-making processes.

Qualification And Education:

Bachelor s degree in Engineering or related field required; Master s degree preferred.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10516350
Position Id: CA_SMEG_0219
Posted 1 day ago

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Senior Manufacturing Engineer

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