Medical Device Mechanical Engineer

Tunnellgov

Bethesda, MD, United States
On-site
Medical device mechanical engineering expertise
Premarket submission experience (510(k), pma)
Analysis of device design and modeling
Tunnell Government Services is seeking a Medical Device Mechanical Engineer with expertise in mechanical engineering and regulatory submissions for medical devices. The ideal candidate will have extensive experience in device mechanical engineering, particularly with FDA submissions, and will work as a subject matter expert to support product development and validation processes

Job Summary

  • Provide scientific, technical, product development, and sustaining engineering advice for regulatory review of medical devices.
  • Analyze device risk to patients, users, and the environment, covering design, materials, prototyping, manufacturing, and human factors.
  • Support analyses of medical devices relative to regulatory and technical aspects of mechanical engineering, including consultation for various marketing applications.

Matching Summary

Match Score: 85

Tunnell Government Services is seeking a Medical Device Mechanical Engineer with expertise in mechanical engineering and regulatory submissions for medical devices. The ideal candidate will have extensive experience in device mechanical engineering, particularly with FDA submissions, and will work as a subject matter expert to support product development and validation processes.

Skills & Requirements

Must-have

  • Medical device mechanical engineering expertise
  • Premarket submission experience (510(k), PMA)
  • Analysis of device design and modeling
  • Familiarity with FDA and ANSI standards

Nice-to-have

  • Strong interpersonal and team collaboration skills
  • Ability to work independently
  • Innovative solution development

Key Requirements

  • Bachelor's degree in engineering or related field
  • 10 years of experience in medical device mechanical engineering
  • Experience supporting FDA 510(k) and related regulatory submissions
  • US Citizen or Full Green Card holder

Work Rights

US Citizen or Full Green Card holder

Tailored Resume

Cover Letter