Sr Manufacturing Engineer Medical device

Job Title: Sr Manufacturing Engineer

Location: San Francisco, CA (Onsite 5 days a week)

Note: Medical device experience is mandatory

Our client, Amaze Systems Inc, is seeking a Sr Manufacturing Engineer for medical device manufacturing. Responsibilities include supporting new and existing manufacturing processes, leading product transfer from R&D to manufacturing, and continuous process improvement.

• Solid Works or similar 3D modeling and design experience.
• Project leadership/management experience and/or leading a team.
• Knowledge of Lean and Six Sigma concepts and root cause problem solving.
• Bachelor's Degree in Engineering or related field required;
  Master's preferred.
• 5+ years of experience in medical device or similar field.
• Experience with continuous process improvement and process validations within a medical device manufacturing environment.
• Strong creative and critical thinking skills.
• Ability to work in a fast‑paced, cross‑functional environment.
• Some travel within the US may be required.
• Experience working in ISO 13485 and FDA regulated environments.

• Support new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
• Support prototype and pilot production, facilities, and planning, when appropriate.
• Interfaces with other departments to solve production problems.
• Investigation and testing of product processes.
• Lead manufacturing efforts associated with new product transfer between R&D and manufacturing.
• Draft and execute validation of product, equipment, and processes.
• Manage builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planning as needed.
• Analyze data and improve processes to assure robust, repeatable manufacturing processes.
• Confers with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems and develop processes.
• Review and/or develop manufacturing and engineering documents.
• Provide solutions to complex problems, including process, equipment, material, supply chain, documentation, equipment validation, IQ/OQ/PQ, PLM, and other applicable QMS / business processes.
• Perform root cause analysis and implement process improvements to improve manufacturing yield.
• Support the design and development of tooling and fixtures to effectively manufacture new and existing products.
• Searches and implements new technologies to improve manufacturing processes and equipment design.
• Demonstrated analytical skills with the ability to present data in meaningful and relevant fashion to aid in decision making.
• Establish and maintain data monitoring for key process metrics in manufacturing.
• Excellent written and verbal communication skills.