Director, Combination Product Development and Human Factors Engineering

Responsibilities

• Manage and execute Design Controls and Drug Development Programs for drug/device combination products
• Lead human factor engineering activities according to regulatory guidelines
• Oversee program execution with design, development, and manufacturing partners to ensure timeline and budget adherence
• Execute Risk Management Programs using tools like DFMEA, UFMEA, and PFMEA in accordance with ISO 14971:2019
• Provide leadership for new products in device design, industrialization, stability, and pilot clinical activities
• Build the company's intellectual property portfolio
• Manage project and program budgets and timelines
• Author and review regulatory submissions
• Report progress, risks, and opportunities to senior management

Requirements

• Bachelors, Masters, or PhD in a technical field (Biomedical, Mechanical, Material, or Systems Engineering preferred)
• Experience in patient-centric drug/device combination product development
• Minimum 10+ years of medical device development experience
• Experience managing external CMOs
• Proficiency in design controls, risk management, and ISO 13485
• Minimum 5+ years managing human factor engineering studies (formative and summative)

Preferred Qualifications

• Demonstrated record of accomplishments such as issued US patents
• Experience taking a device from concept to launch
• Experience with approved drug/device combination products

About the Company

Kaléo is a global leader in drug‑delivery device technology and auto‑injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind.