Director of Human Factors & Lifecycle Engineering

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 148,000 - 287,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY invites a Director of Human Factors to lead HF Engineering and Sustaining Engineering for combination products, shaping usability strategy from development to commercial distribution.

You will recruit and mentor a high-performing team, engage with regulatory bodies, and ensure compliance with IEC 62366, FDA HF guidance, and design controls while driving risk management and post-market surveillance.

Qualifications

• BS/BA in Engineering, Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, or related field preferred.
• Associate Director Human Factors: 10+ years of experience.
• Director Human Factors: 12+ years of experience.
• Previous people leadership experience.
• Experience in medical device, biopharmaceutical combination products, or similarly regulated environment.
• Prior experience with sustaining engineering, design controls, or product lifecycle management for medical devices/combination products.

Responsibilities

• Lead and mentor a high-performing team of human factors and sustaining engineers across development and commercial lifecycle stages.
• Demonstrate people leadership across technical, cross-functional teams under ambiguity with tact and diplomacy.
• Collaborate with product design, engineering, clinical development, marketing, quality, and regulatory affairs; support submission strategy and agency responses for HF 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).
• Ensure usability engineering and design control processes meet regulatory expectations while creating patient value.
• Oversee design changes from concept through implementation; perform design change assessments for supplier and manufacturing changes.
• Drive and document customer complaint investigations (root cause, CAPA) and maintain Risk Management Files.
• Write and edit protocols, risk files, investigation reports, regulatory responses; present risks and priorities to executives and regulators.

Skills

People leadership

Regulatory engagement

Human factors engineering

Design controls

Risk management

Education

BS/BA in Engineering

Human Factors Engineering

Biomedical Engineering

Cognitive Psychology

Human-Computer interaction

Job description

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY invites a Director of Human Factors to lead HF Engineering and Sustaining Engineering for combination products, shaping usability strategy from development to commercial distribution.

You will recruit and mentor a high-performing team, engage with regulatory bodies, and ensure compliance with IEC 62366, FDA HF guidance, and design controls while driving risk management and post-market surveillance.