Senior Sustaining Engineer

4 weeks ago


Reston, Virginia, United States Mantell Associates Full time

Mantell Associates is partnering with a leading Medical Technology firm to find a Senior Sustaining Engineer to support their growing team.

Key Responsibilities:

  • Lead engineering activities to ensure product support throughout the commercialized life cycle
  • Provide engineering expertise for design and process changes of existing products, including change control documentation
  • Develop and implement solutions for complex problems, considering business objectives and cost implications
  • Design and develop manufacturing processes, tooling, and fixtures to meet business needs
  • Support equipment qualifications, process verification, and validation studies
  • Ensure process documentation and validation for manufacturing transfer and scale-up
  • Develop and update work instructions, workmanship standards, and process documents
  • Monitor and assess manufacturing process performance and address emerging issues
  • Provide engineering support for non-conforming products, customer complaints, and CAPAs
  • Support continuous improvement of manufacturing operations for quality, productivity, and cost savings

Requirements:

  • Bachelor's degree in Mechanical or Biomedical Engineering (or related field)
  • 5-8 years of experience in medical device development, production, or regulated industry
  • Experience with ISO 13485 and FDA Quality System Regulations
  • Knowledge of statistical evaluation software and Lean Six Sigma principles
  • CAD experience (preferably SolidWorks)
  • Strong project management skills and ability to prioritize multiple projects
  • Cross-functional team player with excellent engineering and problem-solving skills

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, please contact us.



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