Senior Process Engineer

2 weeks ago

Spencer, United States Gateway Recruiting, INC. Full time
Job Overview

Gateway Recruiting, INC. is seeking a highly skilled Senior Process Engineer to lead the development and commercialization of new technologies. The ideal candidate will have a strong technical background, excellent problem-solving skills, and the ability to drive efficient cross-functional collaboration.

Key Responsibilities:

  • Assess process capabilities, prioritize process improvement opportunities, and implement process improvements on multiple and moderately complex processes.
  • Apply technical knowledge to innovate, design, and develop processes, procedures, tooling, and automation.
  • Execute functional deliverables associated with project management, quality systems, and product development.
  • Prepare and present technical data and recommendations at technical reviews.
  • Write validation protocols and reports applicable to new processes.
  • Ensure proper documentation is completed to meet quality systems requirements.
  • Oversee development builds associated with the project using special work requests.
  • Develop qualified production lines.
  • Provide Design for Manufacturability (DFM) input to the engineering print package.
  • Contribute ideas to or generate Intellectual Property submissions.

Required Qualifications:

  • Bachelor's degree in Mechanical Engineering or Biomedical Engineering or related engineering degree.
  • 5+ years of demonstrated process development/improvement activities.
  • Demonstrated use of Design for Six Sigma tools (DOE, problem-solving).
  • Demonstrated ability to develop processes from concept to production.

Preferred Qualifications:

  • Experience in Agile New Product Development.
  • Medical device or other regulated industry experience.
  • Strong mechanical aptitude, fixture, and equipment design or trouble-shooting experience.
  • Process Development; equipment validations and process characterization and validation experience.
  • Demonstrated understanding and usage of statistics to drive improvements.
  • Experience working with plastics, metals, and various joining methods.

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