Executive Director, Device Development & Delivery Systems

Xeris Pharmaceuticals Inc; Kentucky; On-site; USD 274,000 - 365,000; Full time

Benefits offered by this job

Equity incentive

Annual bonus

Comprehensive benefits

401(k) plan

Job summary

Xeris Pharmaceuticals, Inc. is seeking an Executive Director, Device Development to provide strategic oversight of the device development function, bridging engineering, clinical, quality, regulatory, and commercial teams to reach key milestones.

This role leads a high-performing device engineering organization and ensures design controls and QbD processes guide development. The position manages drug delivery device programs end-to-end, collaborates with partners, and drives submission readiness

Qualifications

• Master’s degree in Biomedical or Mechanical Engineering and 18+ years in pharma/biopharma.
• Minimum 15 years in GMP pharma/biopharma with drug delivery device experience.
• Expertise in development and commercialization of delivery devices and combination products.
• Regulatory expertise for FDA/EU submissions and quality systems.

Responsibilities

• Establish design and development strategies for new and existing drug/device products.
• Lead and retain a high-performing device engineering organization.
• Stay current on applicable regulations, guidances, and standards.
• Represent drug delivery at executive level with cross-functional teams and external partners.
• Oversee technical design criteria and device development in line with specs.

Skills

GMP experience (pharma/biopharma)

Drug delivery device development

Regulatory submissions (FDA/EU)

QbD principles

FDA Design Controls

ISO 13485 knowledge

Project management

CAD software / SOLIDWORKS

Cross-functional leadership

Education

Master’s degree in Biomedical or Mechanical Engineering (or similar)

Tools

SOLIDWORKS

Job description

Xeris Pharmaceuticals, Inc. is seeking an Executive Director, Device Development to provide strategic oversight of the device development function, bridging engineering, clinical, quality, regulatory, and commercial teams to reach key milestones.

This role leads a high-performing device engineering organization and ensures design controls and QbD processes guide development. The position manages drug delivery device programs end-to-end, collaborates with partners, and drives submission readiness