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Manufacturing Engineer

4 months ago

Santa Rosa, United States Endologix Full time

Overview:

Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality, Support new product transfers to manufacturing.

Responsibilities:
  • Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures which are consistent with a zero defect level as well as low product cost.
  • 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.
  • Perform Installation Qualification (IQ) equipment protocols and reports.
  • Provide engineering support to production department in troubleshooting and resolving technical problems.
  • Coordinate work with outside vendors, assigned technicians and tool room personnel.
  • Plan and schedule projects in a manner consistent with corporate objective.
  • 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.
  • Provide engineering support to production department in troubleshooting and resolving technical problems.
  • Work with new product development staff to ensure that new manufacturing processes are designed for manufacturability, help resolve issues.
  • Maintain GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions
  • Complete accurate and timely manufacturing documentation including manufacturing procedures, materials records, etc.
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
  • Ensure that all regulatory and internal policies are followed.
  • Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.
  • Perform other duties as assigned by supervisor
Qualifications:
  • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
  • Utilizes Solid Works drafting skills when appropriate

Education:

  • Requires a Bachelor degree or equivalent in engineering or related discipline.
  • Masters preferred

Experience:

  • Requires a minimum of 2-3 years related experience.

Compensation: $63,000 to 106,000 depending on experience. This position is eligible for a discretionary bonus and equity.