The Delivery Device Engineer will work in collaboration with the Manufacturing and Regulatory teams to develop devices and combination products for Arrowhead's expanding hepatic and extra-hepatic pipeline.
Planning and execution of design approach, verification and validation for medical device and combination drug-product development
Contribute to the preparation of documentation for regulatory submissions
Author and review technical specifications and design control documentation (Design and Development Plans, FMEAs, User Requirements Specifications, Design Inputs, Design Outputs, Design Reviews, Design Verification, Design Validation, and Design Transfer)
Authoring, compilation and maintenance of Design History File content, Conformity Assessments, and Device Master Record (DMR)
Interface with suppliers to address development, risk management, change control, quality or auditing activities
Support New Product Introduction (e.g. Prefilled Syringes, Auto injectors, Inhalation devices etc)
M.S, Ph.D. in Chemistry, Biochemistry or Chemical and biomedical Engineering
10 years of experience in delivery device engineering including a demonstrated level of combination drug-device experience
Technical familiarity required with inhalation drug delivery systems
Familiarity required with device and combination product regulations, guidances and standards
Demonstrated creativity in problem solving
Excellent communication and interpersonal skills to work in team environments.
Ability to stand for extended periods of time
Experience with regulatory writing and submissions through NDA filing
Medical device and combination product quality system experience
Arrowhead Pharmaceuticals, Inc.