Job Description

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

Valid through: 3/27/2021

About Arrowhead Research

Arrowhead Pharmaceuticals is a publicly traded biopharmaceutical company based in Pasadena, California. Arrowhead’s products in development act through RNA interference mechanisms of action. The company focuses on treatments for Hepatitis B, the liver disease associated with alpha 1-antitrypsin deficiency and cardiovascular disease. The company has eight products in its pipeline, in various stages of development. In 2015, the company substantially expanded its intellectual property holdings through complete acquisition of the full RNAi research and development portfolio, and assets from Novartis. In April 2016, it was announced that the former company name, Arrowhead Research Corporation, will be changed to Arrowhead Pharmaceuticals, Inc. In September 2016, Arrowhead entered into two collaboration and licensing agreements with Amgen. Under the deals, Amgen received a worldwide exclusive license to Arrowhead’s ARO-LPA RNAi program and an option to a worldwide exclusive license for ARO-AMG1, both for cardiovascular disease. On Oct. 31, 2018, Arrowhead Pharmaceuticals Inc. closed on a $3.7 Billion License and Collaboration Agreements with Janssen to develop and commercialize ARO-HBV. As part of the overall deal, Arrowhead entered into a research collaboration and option agreement with Janssen to potentially collaborate for up to three additional RNA interference therapeutics against new targets to be selected by Janssen.

Total Jobs:

Average Pay:

$138,947

Total value of jobs:

$5,280,000

% Masters:

100%

Learn More About Arrowhead Research blue arrow

* Ladders Estimates