Position Details
About this role
This role involves leading human factors engineering activities for medical device and drug-device combination product development, ensuring usability and regulatory compliance.
Key Responsibilities
- Lead HFE strategies
- Support device development
- Conduct usability studies
- Author regulatory deliverables
- Perform risk analysis
Technical Overview
Focuses on device design, usability testing, risk analysis, and regulatory documentation for medical devices, especially pre-filled syringes and auto-injectors.
Ideal Candidate
The ideal candidate is a mid-level healthcare device engineer with experience in human factors, usability testing, and regulatory documentation for medical devices, particularly drug-device combinations like pre-filled syringes and auto-injectors.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience in human factors engineering, No background in medical device development, No regulatory documentation experience
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