Manufacturing Engineering SE}

ARCHBartlett, TN
Onsite

About The Position

Contribute to the design, development, and manufacturing of medical devices. Works closely with senior engineers and cross-functional teams to ensure products meet regulatory standards and quality expectations.

Requirements

  • Bachelor’s degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or a related field preferred or equivalent experience.
  • 0-5 years of relevant engineering experience, preferably in the medical device manufacturing industry.
  • Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and other engineering tools.
  • Basic understanding of ISO 13485 and FDA regulations is a plus.
  • Strong analytical and problem-solving skills with the ability to perform detailed analysis and interpret data.
  • Excellent written and verbal communication skills. Ability to clearly document and present technical information.
  • Ability to work effectively in a team-oriented environment and collaborate with cross-functional teams.
  • Strong attention to detail with a commitment to producing high-quality work.

Responsibilities

  • Assist in the design and development of medical devices and components, ensuring compliance with industry standards and regulations.
  • Prepare documentations including Part Processes, Routings, and Inspection documents.
  • Perform detailed analysis and testing to validate product performance and reliability. Document test results and make recommendations for improvements.
  • Prepare and maintain technical documentation, including design specifications, test protocols, and reports.
  • Work collaboratively with cross-functional teams, including R&D, quality assurance, and production, to ensure seamless product development and manufacturing processes.
  • Identify areas for process improvements and support initiatives to enhance product quality and manufacturing efficiency.
  • Assist in troubleshooting and resolving engineering issues that arise during development and production.
  • Ensure that all engineering activities comply with relevant regulatory requirements, quality standards, and company policies.
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