Engineer, Device Engineering

About the role

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.

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.
• Establish, implement, and maintain design control processes and associated Design History File (DHF) documentation.
• Support design transfer activities, including process risk assessments, process specifications, control strategies, and statistical evaluation of specifications.
• Author and review relevant combination product sections of regulatory submissions, including INDs, IMPDs, BLAs, and MAAs.
• Ensure compliance with applicable FDA and EU medical device and combination product regulations and industry standards, including ISO 14971, ISO 13485, and EU MDR.
• Identify technical and program risks, develop mitigation strategies, and communicate issues and recommendations to key stakeholders.
• Manage external vendors and development partners, including project deliverables, timelines, and contracts.
• Manage multiple projects and priorities while maintaining alignment with program timelines and budgets.
• Build and maintain effective relationships with internal stakeholders, external partners, vendors, and testing laboratories.
• Support continuous improvement of device development processes, procedures, and capabilities.

Requirements

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or a related scientific or engineering discipline.
• 8+ years of relevant experience in combination product or medical device development, including experience supporting products from initial concept through commercialization and lifecycle management.
• Demonstrated experience developing and commercializing prefilled syringes and autoinjectors.
• Strong knowledge of subcutaneous drug delivery systems, device design, systems engineering, materials, and manufacturing processes.
• Demonstrated experience implementing and managing design controls and risk management processes.
• Experience leading human factors and usability engineering activities, including formative and summative evaluations, usability risk assessments, and preparation of plans, protocols, and reports.
• In-depth knowledge of applicable FDA and EU medical device and combination product regulations, quality systems, and industry standards, including ISO 14971, ISO 13485, and EU MDR.
• Experience overseeing device characterization and design verification testing.
• Experience authoring or contributing to device-related sections of regulatory submissions.
• Proven experience managing external vendors and development partners.
• Excellent written and verbal communication skills with the ability to communicate complex technical information to a variety of audiences.
• Demonstrated ability to influence and collaborate effectively across functions and with external partners.
• Strong organizational and project management skills with the ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Advanced degree in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or a related field.
• Experience with biological drug products and primary packaging development.
• Experience with cGMP process development, manufacturing controls, process risk assessments, and design transfer.
• Experience working in a fast-paced or high-growth biotechnology/pharmaceutical environment.
• Demonstrated experience mentoring or providing technical leadership to other engineers and scientists.

Pay

Wisconsin pay range: $120,000 USD - $145,000 USD. California pay range: $135,000 USD - $155,000 USD. Arrowhead provides competitive salaries and an excellent benefit package.