Director Human Factors & Sustaining Engineering

Regeneron Pharmaceuticals•Rensselaer, IN

3d•$147,800 - $286,900•Onsite

About The Position

Regeneron's Combination Product Development team is seeking a Director of Human Factors to lead the Human Factors Engineering team and oversee the Sustaining Engineering function. This role involves shaping patient and caregiver interaction with medical devices and ensuring the quality, compliance, and performance of commercial products. The position requires a strong understanding of design control processes, from initial usability studies through long-term commercial distribution.

Requirements

BS/BA in Engineering, Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, Human-Computer interaction or related field is preferred.
Associate Director Human Factors: 10+ years of experience
Director Human Factors: 12+ years of experience
Level will be determined based on experience
Previous people leadership experience
Experience in medical device, biopharmaceutical combination products, or a similarly regulated environment
Prior experience with, or oversight of, sustaining engineering, design controls, or product lifecycle management for medical devices/combination products

Responsibilities

Recruit, direct, mentor, and retain a high-performing team of human factors and sustaining engineers supporting multiple projects across development and commercial lifecycle stages.
Build onboarding and career pathways that help engineers across both disciplines grow.
Bring prior people-leadership experience across technical, cross-functional teams, with the ingenuity and composure to prioritize competing demands under ambiguity, tact, and diplomacy.
Build strong working relationships and move seamlessly across product design, engineering, clinical development, marketing, quality, and regulatory affairs including on submission strategy, content, and agency responses for HF-related questions.
Serve as internal expert on human factors and combination product regulations/standards (IEC 62366, AAMI HE75, ISO 14971, FDA HF guidance, 21 CFR Part 4, 21 CFR 820 design controls, ICH Q8-Q11).
Ensure usability engineering and design control processes meet and exceed regulatory expectations while delivering real patient value.
Apply end-to-end understanding of design control (inputs/outputs, V&V, design transfer, change control) to connect usability findings and sustaining changes back to the Design History File, keeping documentation aligned as products move from development to commercial distribution.
Own design changes from concept through implementation; conduct design change assessments and technical evaluations for supplier, component, and manufacturing changes, including global filings and contract manufacturing changes as commercial footprint expands.
Drive and document customer complaint investigations (root cause, CAPA) and maintain/evolve Risk Management Files using post-market surveillance and manufacturing data, with hands-on DHF/RMF management experience.
Write and edit clear, accurate technical documentation (protocols, risk files, investigation reports, regulatory responses) and hold the team to the same standard.
Present team work, risks, and priorities to executive management and regulatory authorities, advising on process improvements and emerging regulatory issues.