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Process Development Engineer II

2 months ago

Minneapolis, Minnesota, United States Resolution Medical Full time
Job Summary

This Process Development Engineer works collaboratively to lead the development of complex medical devices and ensures effective transfer of designs into production.

Key Responsibilities
  • Develop processes used to manufacture components, sub-assemblies, and finished goods devices to bring products to a commercialized state.
  • Act as liaison between development and operations teams to advocate for repeatable processes that meet design requirements.
  • Prepare and present detailed plans necessary to complete assigned projects, including schedule milestones, manpower, facility, and equipment coordination.
  • Assist in improving production controls, standard operating procedures, safety, quality control, and training.
  • Design, develop, and test tools, machinery, and equipment for recommended manufacturing methods, providing ROI analysis.
  • Perform product/process analysis for production and quality metrics, writing engineering change orders as necessary.
  • Support company finance, accounting, human resources, quality, regulatory, and clinical departments to ensure compliance with requirements.
Requirements
  • Bachelor's degree in engineering or related field (equivalent work experience may be considered).
  • 2 years related experience.
  • Demonstrated ability to develop medical device manufacturing processes from concept to production.
  • Experience with medical device Design For Manufacturing, design control, quality systems, and product development phases.
  • Strong oral and written communication skills, problem-solving skills, and cross-functional teamwork ability.
  • Ability to work in a fast-paced, constantly changing environment and travel to support projects and customer requirements.
  • MS Office proficiency and physical requirements including prolonged sitting, lifting up to 25 pounds, and wearing personal protective equipment.