What are the responsibilities and job description for the Medical Device Engineer III (DHF, design history files) position at The Fountain Group?
100% ONSITE NORTH CHICAGO IL
PAY: $57-$62/hr
REQUIRED:
- Experince managing DHF/design changes for existing medical devices and can perform hands-on verification testing. Supplier change experience is a plus
- DHF / Design Controls: Strong hands-on DHF experience, particularly managing changes to existing, on-market medical devices. This is the biggest priority.
- Medical Device Experience: Experience supporting Class I–III devices, including product lifecycle changes.
- Lab Testing: Must be comfortable writing verification protocols, executing physical testing, and documenting results.
- Regulatory Knowledge: Familiarity with ISO 13485, EU MDR, and applicable design control requirements.
- Education / Experience: Bachelor's degree required, along with several years of relevant industry experience. No recent graduates.
Nice-to-Haves
- Supplier change experience is preferred, but not required.
- Combination product experience.
- Quality engineering background with strong technical/design control knowledge.
- Advanced degree (master's or PhD). PhD candidates are not considered overqualified.
- Experience in large medical device or pharmaceutical organizations.
JOB DESCRIPTION:
This position supports on-market Class I–III medical devices, with a heavy focus on DHF, design changes, and hands-on laboratory testing. The manager needs someone experienced who can get up to speed quickly and work independently within approximately one month.
The role is roughly 60% lab testing and 40% documentation/protocol writing, depending on the project.
Salary : $57 - $62