Delivery Device Engineer

Arrowhead Pharmaceuticals, Inc. Madison , WI 53706

Posted 2 months ago

The Position

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.

Responsibilities

  • 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)

Requirements:

  • 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

Preferred:

  • Experience with regulatory writing and submissions through NDA filing

  • Medical device and combination product quality system experience

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Delivery Device Engineer

Arrowhead Pharmaceuticals, Inc.