Director Human Factors & Sustaining Engineering
Regeneron · Tech Valley +1 more
OtherFull-time$148k–$287kCompany career page
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
What they're looking for
- BS/BA in Engineering, Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, or related field
- 10+ years experience (Associate Director level) or 12+ years (Director level) in relevant field
- Proven people leadership experience with technical, cross-functional teams
- Medical device, biopharmaceutical combination product, or regulated industry background
- Prior experience with sustaining engineering, design controls, or product lifecycle management
- Knowledge of IEC 62366, AAMI HE75, ISO 14971, FDA guidance, and 21 CFR design control regulations
What you'll be doing
- Recruit, mentor, and develop human factors and sustaining engineering teams across development and commercial stages
- Lead usability study strategy, execution, and regulatory submissions for combination products in development
- Oversee design control processes including verification, validation, design transfer, and change management
- Conduct design change assessments and manage customer complaint investigations with root cause and CAPA documentation
- Author and review technical documentation including protocols, risk management files, and regulatory responses for agency submissions
Privacy & handoff
This role links to Regeneron's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.