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Sr. Manufacturing Engineer
Sr. Manufacturing EngineerEndologix LLC • Santa Rosa, CA, US
Sr. Manufacturing Engineer

Sr. Manufacturing Engineer

Endologix LLC • Santa Rosa, CA, US
[job_card.30_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Overview

Support daily operations along with design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

Responsibilities

  • Design and develop manufacturing processes for new products and/or changes to existing products
  • Design and develop fixtures and tooling for manufacturing process
  • Develop and execute process validation protocols (IQ/OQ/PQ)
  • Analyze process data and make decisions/recommendations relating to process capability and DFM
  • Perform Installation Qualification (IQ) equipment protocols and reports
  • Investigate benefits and features of capital equipment and generate capital appropriation justifications
  • Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions
  • Provide engineering support to production department in troubleshooting and resolving technical problems.
  • Contact and address component and/or raw material issues with suppliers
  • Support manufacturing and quality with addressing NCMR issues
  • Plan, schedule, and complete projects in a manner consistent with business objectives
  • Contribute to the intellectual property position of the company via invention and patent applications
  • Maintain accurate documentation of concepts, designs, and processes.
  • Maintain current knowledge of medical, technical, and biomedical developments as related to company products.
  • Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
  • Work with product development staff to ensure that design for manufacturability principles are applied to new processes and any issues are resolved
  • Maintain GMP compliance relating to Document Control, R&D, and Quality Assurance
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
  • Ensure that all regulatory and internal policies are followed
  • Assist engineering manager in development of engineers providing assistance with coaching and mentoring
  • Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.
  • Perform other duties as assigned by supervisor

Qualifications

  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
  • Has the ability to use moderate to advanced statistic techniques when analyzing data and make rational and logical decision base the that analysis
  • Applicable knowledge of Minitab, JMP, or other statistic tools
  • Applicable knowledge of Solidworks or other CAD software (not a requirement but a desirable skill)
  • May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
  • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.

Education:

  • Requires a Bachelop of Science degree in Engineering or related technical degree (i.e. physics or mathematics)

Experience:

  • Five years with a Bachelor's degree, Three years with a Master's degree of directly relevant


Compensation: $100,000- $130,000

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Sr. Manufacturing Engineer • Santa Rosa, CA, US

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