Executive Director, Device Development

Role: Executive Director of Device Development providing strategic and operational leadership for Xeris' combination product and device development functions. Responsibilities: oversee design, development, and commercialization of drug/device products, manage cross-functional teams including engineering, quality, regulatory, and clinical; ensure compliance with GMP, FDA, and EU regulations; develop and implement strategies for new and existing products, and manage relationships with partners. Qualifications: Master's in Biomedical or Mechanical Engineering; 18+ years in pharma/biopharma, with 15+ years in GMP environments focusing on drug delivery devices and combination products; strong expertise in regulatory standards (FDA, EU), design controls, quality systems (ISO 13485, 21CFR820), and project management from proof-of-concept to commercialization. High-Value: extensive experience in device development, regulatory submissions, and cross-functional leadership in biologics/pharmaceuticals; working knowledge of CAD/SOLIDWORKS; ability to navigate FDA and EU regulations; leadership in GMP/ISO standards. Work setup: based in Chicago, onsite five days/week, with travel and occasional after-hours work.