Process Development Engineer I

2 weeks ago


Fridley, United States Resolution Medical Full time

Job Type

Full-time

Description

Job Summary

The Process Development Engineer I position develops, improves and implements optimal cost-effective and complaint manufacturing processes and methods in accordance with product specifications and quality standards; invents, develops and implements mechanized processes to reduce variation, increase capabilities and ensures all processes are trainable.

Essential Functions

  • Works with project teams to develop the processes used to manufacture components, sub-assemblies and FG devices to bring the product to a commercialized state.
  • Acts as the liaison between development and operations
  • Advocates for the process to ensure they are repeatable, and the process can capability produce product that meets the design requirements
  • Prepares and presents detailed plans necessary to complete assigned projects.
  • Develops schedule milestones, coordinates manpower, facility and equipment for assigned projects
  • Assists in improving the system of production controls, standard operating procedures, safety, quality control and training.
  • Prepares and maintains detailed layouts of buildings and equipment.
  • Coordinates the manufacturing launch of new/revised products including establishing goals, training team members and evaluating results.
  • Designs, develops and tests as well as sources various tools, machinery and equipment for recommended manufacturing methods while providing ROI analysis.
  • Performs product/process analysis for production and quality metrics.
  • Write engineering change orders to process changes to manufacturing documents, drawing, and Bill of Materials
  • Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.
Requirements

Education, Experience, Required Skills
  • Bachelor's degree in engineering (equivalent work experience may be considered)
  • 1-2 years of experience in medical device industry
  • Experience with programs including SolidWorks preferred
  • Strong oral and written communication skills
  • MS Office Proficiency
  • Strong problem-solving skills to identify, gather, and analyze information develop solutions and resolve problems in a timely manner
  • Ability to handle and be trusted with confidential and/or sensitive information
  • Ability to work in a fast-paced, constantly changing environment
  • Ability to travel to support projects and customer requirements
Physical Requirements
  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift up to 25 pounds at times.
  • Must have excellent hand-eye coordination.
  • Ability to differentiate between colored wires, tabs, and electronic components.
  • Must wear gown, gloves, and ear protection if applicable.

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