Development Engineer
$85,000–$95,000 year
On-siteLeesburg, Virginia, United States or Allendale, Michigan, United States
Job Summary
Interface with surgeons to gather input for designs and evaluate new and existing products. Collaborate with R&D, Quality, Manufacturing, Regulatory, Clinical, and Project Management teams to ensure project success. Design, develop, modify, evaluate, and verify components for medical devices under supervision while participating in cadaver labs to ensure user needs are met. Create and refine engineering documentation including Design History Files, Change Control records, and Regulatory Technical files. Assist with prototyping, bench testing, and support problem-solving and root cause analysis. Prepare and review information for invention disclosures and patent applications. Participate in design reviews and develop foundational knowledge of industry standards aligned with regulatory requirements.
Required Qualifications
- Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or related discipline
- 1+ year of experience
- Ability to read and interpret complex engineering drawings
- Ability to set and manage personal priorities in a regulated environment
Desired Qualifications
- Master's degree
- medical device industry experience
- Co-Op or Internship experience
- Basic experience with a parametric CAD package (Creo or SolidWorks)
- Fundamental knowledge of mechanical engineering practices, design principles, materials, and manufacturing methods (traditional and additive)
- Basic knowledge of analysis tools and statistical methods
- Strong willingness to learn, take ownership, and work effectively under supervision
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