Senior Manufacturing Engineer

4 weeks ago


Santa Rosa, United States Meet Full time

Responsibilities:

  • Develop manufacturing processes for new products and modifications to existing ones.
  • Create fixtures and tooling necessary for the manufacturing process.
  • Execute process validation protocols (IQ/OQ/PQ).
  • Analyze process data to enhance process capability and Design for Manufacturability (DFM).
  • Conduct Installation Qualification (IQ) equipment protocols and prepare related reports.
  • Evaluate the advantages and specifications of capital equipment and justify capital appropriation.
  • Maintain accurate documentation including concepts, designs, tool drawings, and shop orders in collaboration with Quality Assurance and R&D departments.
  • Offer engineering support to production for troubleshooting and resolving technical issues.
  • Communicate with suppliers to address component and raw material concerns.
  • Assist manufacturing and quality teams in addressing Non-Conforming Material Report (NCMR) issues.
  • Manage projects in alignment with business objectives.
  • Contribute to the company's intellectual property through invention and patent applications.
  • Stay updated on medical, technical, and biomedical advancements relevant to company products.
  • Support prototype and pilot production efforts for new products, modifications, and enhancements.
  • Collaborate with product development to ensure designs are manufacturable and resolve any associated issues.
  • Maintain compliance with Good Manufacturing Practices (GMP) pertaining to Document Control, R&D, and Quality Assurance.
  • Uphold company policies, procedures, and regulatory requirements, including FDA regulations.
  • Provide coaching and mentorship to engineers, assisting in their development.
  • Identify and mitigate hazards associated with process Failure Mode and Effects Analysis (FMEA).
  • Fulfill other duties as assigned by supervisor.


Qualifications:

  • Exercise judgment within established practices and policies.
  • Proficiency in using moderate to advanced statistical techniques for data analysis and decision-making.
  • Knowledge of statistical tools like Minitab, JMP, or equivalent.
  • Familiarity with Solid works or other CAD software (preferred but not required).
  • May establish methods and procedures for new assignments and offer guidance to junior staff.
  • Address complex problems requiring in-depth evaluation of various factors.


Education:

  • Bachelor of Science degree in Engineering or a related technical field.


Experience:

  • Five years of relevant experience with a Bachelor's degree, or three years with a Master's degree.


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