Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

Arrowhead Pharmaceuticals is seeking a highly skilled and experienced Engineer to support device and combination product development. This role will provide technical leadership for the strategy, development, and execution of drug-device combination product programs from early concept through commercialization and lifecycle management.

The successful candidate will bring deep expertise in drug delivery systems, human factors engineering, design controls, risk management, and medical device regulations, with demonstrated experience developing prefilled syringes and autoinjectors. This individual will partner closely with cross-functional teams, including Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, and Regulatory Affairs, to ensure combination products are developed in accordance with applicable regulatory requirements and meet patient needs.

The ideal candidate is a collaborative and highly organized technical leader who can manage multiple priorities, communicate complex information effectively, and influence internal and external stakeholders.

Responsibilities

Develop and execute strategies and technical roadmaps for drug-device combination product development aligned with program and company objectives.
Provide technical leadership for combination product development from concept through commercialization and lifecycle management.
Lead human factors and usability engineering activities to support safe and effective product use.
Author and review human factors/usability engineering plans, usability risk assessments (URRAs), study protocols and reports, and supporting design control documentation.
Lead and support formative and summative human factors evaluations, including study oversight and interpretation of results.
Provide technical expertise in drug delivery technologies, device design, systems engineering, design controls, risk management, materials, and manufacturing processes.
Lead development activities for prefilled syringes, autoinjectors, and other drug delivery systems.
Collaborate cross-functionally with Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, and Regulatory Affairs to support successful program execution.
Oversee external testing laboratories supporting device characterization, design verification, and other development activities, including authoring and reviewing protocols and reports.