Director Human Factors & Sustaining Engineering
Core
Lead Human Factors Engineering and Sustaining Engineering for medical device combination products, ensuring patient safety, regulatory compliance, and product performance from development through commercial lifecycle.
Role type
Director, dual-scope leadership (Human Factors & Sustaining Engineering)
Builds
Combination products (prefilled syringes, autoinjectors) for patients with serious diseases
Domain
Biopharmaceuticals / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
People leadership, cross-functional collaboration, regulatory strategy, design control management, risk management, complaint investigation, technical documentation, change control
Preferred skills
Experience in medical device or biopharmaceutical combination products, oversight of sustaining engineering, product lifecycle management
Technologies
IEC 62366, AAMI HE75, ISO 14971, FDA HF guidance, 21 CFR Part 4, 21 CFR 820, ICH Q8-Q11
Responsibilities
Recruit and mentor high-performing teams of human factors and sustaining engineers; drive usability strategy and study execution; oversee quality, compliance, and performance of commercial products; manage design changes and supplier/component evaluations; lead customer complaint investigations and risk management files; present work and risks to executive management and regulatory authorities
Seniority
Director, strategic leadership with hands-on technical oversight
