Director Human Factors & Sustaining Engineering (Medical Devices)

Location: East Greenbush, New York, United States. Onsite Monday–Friday, 8:00 a.m.–5:00 p.m.; approximately 15% domestic and occasional international travel.

Company

hirify.global is a biotechnology company that develops and commercializes medicines and combination products for serious diseases.

What you will do

• Lead, recruit, mentor, and retain a team of human factors and sustaining engineers across development and commercial lifecycle stages.
• Set usability strategy, oversee human factors studies, and support regulatory submissions, agency responses, and combination product compliance.
• Apply design control principles across design inputs and outputs, verification and validation, design transfer, change control, and Design History File maintenance.
• Own design changes from concept through implementation, including supplier, component, manufacturing, and contract manufacturing changes.
• Lead customer complaint investigations, root-cause analysis, CAPA, post-market surveillance, and Risk Management File updates.
• Present technical work, risks, priorities, and regulatory issues to executive management and regulatory authorities.

Requirements

• 12+ years of experience for the Director Human Factors level; level may be determined based on experience.
• Bachelor’s degree in Engineering, Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, Human-Computer Interaction, or a related field preferred.
• Previous people-leadership experience across technical and cross-functional teams.
• Experience in medical devices, biopharmaceutical combination products, or a similarly regulated environment.
• Experience with sustaining engineering, design controls, or product lifecycle management for medical devices or combination products.
• Working knowledge of IEC 62366, AAMI HE75, ISO 14971, FDA human factors guidance, 21 CFR Part 4, 21 CFR 820 design controls, and ICH Q8–Q11.

Culture & Benefits

• Inclusive workplace and equal employment opportunity environment.
• Competitive total rewards package that may include annual incentives, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Onsite work is expected for many roles, with specific expectations determined by the role and location.