Senior Device Engineer - Drug-Device Combinations & HF

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 150,000 - 210,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a highly skilled Engineer to lead drug-device combination product development from concept through commercialization and lifecycle management.

The role requires deep expertise in drug delivery systems, human factors engineering, design controls, risk management, and regulatory affairs to ensure compliant, patient‑centered products across cross‑functional programs.

Qualifications

• Bachelor's degree in a scientific or engineering discipline is required.
• 8+ years of experience in combination product or medical device development, from concept through commercialization.
• Experience developing and commercializing prefilled syringes and autoinjectors.
• Strong knowledge of subcutaneous drug delivery systems, device design, systems engineering, materials, and manufacturing processes.
• Experience implementing and managing design controls and risk management processes.

Responsibilities

• Develop strategies and roadmaps for drug-device combination product development aligned with program and company objectives.
• Provide technical leadership for 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 URAs, study protocols and reports, and design control documentation.
• Lead formative and summative human factors evaluations and oversee study results interpretation.
• Provide expertise in drug-delivery technologies, device design, and manufacturing processes.
• Lead development activities for prefilled syringes and autoinjectors.
• Collaborate with cross-functional teams to support program execution.
• Oversee external testing laboratories and author/ review protocols and reports.
• Maintain design control processes and DHF documentation.
• Support design transfer activities and risk assessments.

Skills

Project management

Technical leadership

Regulatory knowledge

Cross-functional collaboration

Communication

Education

Bachelor's degree in Biomedical Engineering or related field

Job description

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a highly skilled Engineer to lead drug-device combination product development from concept through commercialization and lifecycle management.

The role requires deep expertise in drug delivery systems, human factors engineering, design controls, risk management, and regulatory affairs to ensure compliant, patient‑centered products across cross‑functional programs.