Manufacturing Engineer

Operations San Francisco, California


Description

Spire Health is currently seeking an experienced Manufacturing Process Engineer. The purpose of this position is to fulfill Spire Health’s manufacturing need for a full time hands-on technical expert in medical device manufacturing and process engineering.  The Manufacturing Engineer will provide support for production of currently marketed wellness products, new medical device product introduction (NPI), product changes, testing and capacity scale-up.

Responsibilities:

  • Perform root cause analysis, analyze and present data, implement process improvements to improve yield and manufacturing process robustness and compliance.
  • Prepare and review manufacturing procedures, test protocols and reports, and other controlled documentation, including training of operators.
  • Provide technical support to supply chain, interacting with suppliers of critical components for investigation of technical nature, qualification of new and existing processes, qualification of new suppliers and capacity scale up
  • Lead design and validation of mold tools in support of capacity increase, and new products/components.
  • Lead validation efforts of equipment, tooling, processes and product manufacturing.
  • Own all validation related activities of writing IQ, OQ, PQ protocols, executing the validation with partnership with R&D and Operations, writing reports and closing out of documents.
  • Interfaces cross-functionally to identify and implement improvements, solve production related problems and support resolution of manufacturing related non-compliances related to process, equipment, material, supply chain, documentation, and equipment validation.

Qualifications:

  • Bachelor’s Degree in Engineering or a related field required; Master’s degree preferred
  • Must have at least 5-10 years of related experience in engineering, manufacturing and production within FDA regulated medical device industries.
  • Proven experience designing and executing process and equipment validation
  • Experience with Continuous Process Improvement, Lean Manufacturing, pFMEA risk analysis, statistical data analysis and various root cause analysis tools.
  • Strong creative and critical thinking skills
  • Ability to work in a fast-paced, cross-functional environment
  • Some travel may be required - must be able to travel within the US and eventually Asia
  • Experience working in ISO 13485 and FDA regulated environments
  • Excellent written and verbal communication skills
  • Demonstrated analytical skills with the ability to present data in meaningful and relevant fashion to aid in decision making process
  • Experience in 3D solid modeling (such as NX or SolidWorks), and use of statistical tools.
  • Experience leading project teams a plus
  • Speaking Mandarin is a plus

Spire Health also provides additional benefits and is an Equal Opportunity Employer (M/F/V/D).