Device Engineer III

Role: Device Engineer III supporting drug-device combination products across the commercial lifecycle, focusing on commercialization and sustaining engineering activities. Responsibilities include representing Device Development on cross-functional teams, implementing post-launch changes, supporting complaint investigations, managing risk per ISO 14971, maintaining Design History Files, and executing design transfer activities. Qualifications: 5+ years experience with a BS/BA or 3+ years with an MS in relevant fields; expertise in ISO 13485, risk management, root cause analysis, change control, and vendor collaboration. Preferred skills include experience with mechanical assembly processes, Solidworks or similar CAD tools, and familiarity with ICH Q7-Q10 guidelines, project management, and statistical analysis methods. High-value biopharma specifics: focus on combination products, manufacturing support, lifecycle management, and compliance with regulatory standards; experience in medical devices for drug delivery systems is advantageous. Work setup: not specified, but involves collaboration with manufacturing sites and external partners.