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Process Development Engineer II

2 months ago

Minneapolis, Minnesota, United States Silk Road Medical, Inc. Full time
About the Role

We are seeking a highly skilled Process Development Engineer II to join our team at Silk Road Medical, Inc. in Sunnyvale, California and Plymouth, MN. As a key member of our cross-functional New Product Development (NPD) project teams, you will contribute to the development of innovative medical devices that reduce the risk of stroke.

Key Responsibilities
  • Contribute to the development of manufacturing processes, PFMEA, and manufacturing pilot/qualification builds.
  • Design and perform process characterization and development activities, including screening experiments, DOE, process mapping, and equipment design and selection.
  • Design and qualify process tooling, fixtures, and equipment, with varying degrees of semi-automation.
  • Create protocols, perform testing, analyze results, and document reports for process characterization and qualification activities.
  • Develop manufacturing documentation, including SOPs and records.
  • Contribute to PFMEA activities and perform job safety risk assessments for new processes and equipment designs.
  • Lead aspects of manufacturing pilot builds and IQ, OQ, PQ.
  • Develop manufacturing processes with a focus on ergonomics, safety, Lean methodologies, waste reduction, one-piece flow, and Cycle Time / TAKT Time considerations.
Requirements
  • Bachelor's degree in Engineering or a related field.
  • 2+ years of process development experience in a manufacturing environment, with medical device experience preferred.
Additional Skills
  • Ability to solve problems and deal with a variety of variables in pressure situations.
  • Effective verbal and written communication skills.
  • Excellent attention to detail, flexibility, and adaptability to change.
  • Ability to design fixtures and components in SolidWorks (CAD).
  • Advanced analytical and mathematical skills, including basic statistics.
  • Self-motivation, high organization, and resourcefulness in using scientific and engineering principles to solve manufacturing issues.
  • Well-developed team orientation with strong critical thinking and analytical skills.
  • Working knowledge of DFM, Lean Six Sigma methodologies, DOE, and Statistical Process Control.
  • Occasional lifting or moving of objects up to 50 lbs.
  • Occasional repetition of motions that may include the wrists, hands, and/or fingers.
  • Travel up to 10%.