Director of Human Factors & Sustaining Engineering

Quick Facts

• Role: Director of Human Factors & Sustaining Engineering (dual-scope leadership)

• Location: East Greenbush, New York, United States

• Work model: Monday–Friday, 8am–5pm

• Travel: ~15% domestic; occasionally international

Description

Lead the Human Factors Engineering team and the Sustaining Engineering function for combination products. Own usability engineering strategy, study execution, and regulatory engagement, while safeguarding long-term quality, compliance, and performance after launch. The role focuses on combination product design controls and connecting usability findings and sustaining changes to the Design History File and Risk Management File.

Responsibilities

• Recruit, direct, mentor, and retain a high-performing engineering team across development and commercial lifecycle stages

• Apply people-leadership experience and prioritize competing demands under ambiguity

• Collaborate across product design, engineering, clinical development, marketing, quality, and regulatory affairs, including human factors submission strategy and agency responses

• Act as an internal expert on human factors regulations/standards and ensure usability engineering and design control processes meet regulatory expectations

• Use end-to-end design control expertise (inputs/outputs, verification & validation, design transfer, change control) to link usability and sustaining changes to DHF documentation

• Own design changes from concept through implementation; assess supplier/component/manufacturing changes and support global filings and contract manufacturing expansions

• Lead customer complaint investigations (root cause, CAPA) and maintain/evolve Risk Management Files using post-market surveillance and manufacturing data

• Produce and review technical documentation (protocols, risk files, investigation reports, regulatory responses) and present risks/priorities to executive management and regulators

Requirements

• BS/BA in Engineering, Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, Human-Computer Interaction, or related field (preferred)

• Previous people leadership experience

• Experience in medical device, biopharmaceutical combination products, or a similarly regulated environment

• Prior experience overseeing sustaining engineering, design controls, or product lifecycle management for medical devices/combination products

• Associate Director track: 10+ years of human factors experience; Director track: 12+ years

Benefits

• Competitive total rewards package (country/role dependent), potentially including bonuses/incentives, equity awards, retirement benefits and 401(k) match, health and wellness programs, insurance (medical/dental/vision/life/disability), paid time off, and family support benefits

• Salary range (annual): $147,800.00–$286,900.00