Director, Human Factors – Sustaining Engineering

Jobtailor; Town of East Greenbush (NY); On-site; USD 180,000 - 230,000; Full time

Job summary

Jobtailor seeks an experienced Human Factors leader to direct a high-performing team across human factors and sustaining engineering. You will drive strategy, usability study execution, regulatory engagement, and design controls for medical device products in development and post-market phases.

The role requires extensive leadership experience in regulated environments, deep expertise in IEC 62366, ISO 14971, FDA guidance, and a strong track record in design history file management and lifecycle

Qualifications

• 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
• 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
• Solid command of design inputs and outputs, verification and validation, design transfer, and change control
• Expertise in human factors and combination product regulations/standards, including IEC 62366, AAMI HE75, ISO 14971, FDA human factors guidance, 21 CFR Part 4, 21 CFR 820 design controls, and ICH Q8-Q11
• Hands‑on DHF/RMF management experience
• Ability to travel 15% domestically and occasionally internationally

Responsibilities

• Recruit, direct, mentor, and retain a high-performing team of human factors and sustaining engineers
• Build onboarding and career pathways for engineers across both disciplines
• Lead human factors engineering strategy, usability study execution, and regulatory engagement for products in development
• Oversee sustaining engineering for commercial combination products
• Build relationships across product design, engineering, clinical development, marketing, quality, and regulatory affairs
• Support submission strategy, content, and agency responses for human-factors-related questions
• Serve as internal expert on human factors and combination product regulations and standards
• Ensure usability engineering and design control processes meet regulatory expectations and deliver patient value
• Connect usability findings and sustaining changes to the Design History File
• Own design changes from concept through implementation
• Conduct design change assessments and technical evaluations for supplier, component, and manufacturing changes
• Manage global filings and contract manufacturing changes
• Drive and document customer complaint investigations, root cause analysis, and CAPA
• Maintain and evolve Risk Management Files using post-market surveillance and manufacturing data
• Write and edit protocols, risk files, investigation reports, and regulatory responses
• Present team work, risks, and priorities to executive management and regulatory authorities
• Advise on process improvements and emerging regulatory issues

Skills

Human Factors Engineering

Regulatory Compliance

Usability Study Execution

Design Control Processes

Sustaining Engineering

Root Cause Analysis

CAPA

Risk Management

Education

BS/BA in Engineering or related field

Job description

• Recruit, direct, mentor, and retain a high-performing team of human factors and sustaining engineers
• Build onboarding and career pathways for engineers across both disciplines
• Lead human factors engineering strategy, usability study execution, and regulatory engagement for products in development
• Oversee sustaining engineering for commercial combination products
• Build relationships across product design, engineering, clinical development, marketing, quality, and regulatory affairs
• Support submission strategy, content, and agency responses for human-factors-related questions
• Serve as internal expert on human factors and combination product regulations and standards
• Ensure usability engineering and design control processes meet regulatory expectations and deliver patient value
• Connect usability findings and sustaining changes to the Design History File
• Own design changes from concept through implementation
• Conduct design change assessments and technical evaluations for supplier, component, and manufacturing changes
• Manage global filings and contract manufacturing changes
• Drive and document customer complaint investigations, root cause analysis, and CAPA
• Maintain and evolve Risk Management Files using post-market surveillance and manufacturing data
• Write and edit protocols, risk files, investigation reports, and regulatory responses
• Present team work, risks, and priorities to executive management and regulatory authorities
• Advise on process improvements and emerging regulatory issues

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
• 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
• Solid command of design inputs and outputs, verification and validation, design transfer, and change control
• Expertise in human factors and combination product regulations/standards, including IEC 62366, AAMI HE75, ISO 14971, FDA human factors guidance, 21 CFR Part 4, 21 CFR 820 design controls, and ICH Q8-Q11
• Hands‑on DHF/RMF management experience
• Ability to travel 15% domestically and occasionally internationally

Core Competencies

Demonstrates expertise in human factors engineering and regulatory compliance for medical devices, with a strong focus on usability study execution, design control processes, and risk management. Proven ability to lead and mentor teams while driving product development and sustaining engineering strategies.

Highest-signal resume keywords

• Human Factors Engineering
• Regulatory Compliance
• Usability Study Execution
• Design Control Processes
• Sustaining Engineering

Hard Skills

• Design Inputs and Outputs
• Verification and Validation
• Design Transfer
• Change Control
• DHF Management
• RMF Management
• Root Cause Analysis
• CAPA
• Risk Management
• Technical Evaluations

Soft Skills

• People Leadership
• Mentoring
• Relationship Building
• Process Improvement
• Communication

Industry Keywords

• Medical Device
• Biopharmaceutical Combination Products
• IEC 62366
• AAMI HE75
• ISO 14971
• FDA Human Factors Guidance
• 21 CFR Part 4
• 21 CFR 820
• ICH Q8-Q11
• Post-Market Surveillance