Process Development Engineer II

at  RESOLUTION MEDICAL LLC

JOB SUMMARY

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

EDUCATION, EXPERIENCE, REQUIRED SKILLS

• 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
• Strong problem-solving skills to identify, gather, and analyze information develop solutions and resolve problems in a timely manner
• Demonstrated cross functional teamwork
• Ability to work in a fast-paced, constantly changing environment.
• Ability to travel to support projects and customer requirements
• MS Office Proficiency

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.

• Works with project teams to develop the processes used to manufacture component, 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: