Engineer, Device Engineering
Arrowhead Pharmaceuticals
August 07, 2026
Remote friendly (Los Angeles, CA)
United States
Operations
Responsibilities:
- Develop and execute strategies and technical roadmaps for drug-device combination product development.
- Provide technical leadership from concept through commercialization and lifecycle management.
- Lead human factors and usability engineering activities, including authoring/reviewing plans, usability risk assessments (URRAs), study protocols/reports, and design control documentation.
- Lead and support formative/summative human factors evaluations and interpret results.
- Provide technical expertise in drug delivery technologies, device design, systems engineering, design controls, risk management, materials, and manufacturing processes.
- Lead development of prefilled syringes, autoinjectors, and other drug delivery systems.
- Partner cross-functionally (Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, Regulatory Affairs).
- Oversee external testing laboratories and author/review protocols and reports.
- Establish/maintain design control processes and Design History File (DHF) documentation.
- Support design transfer (process risk assessments, specifications, control strategies, statistical evaluation).
- Author/review combination product sections of regulatory submissions (INDs, IMPDs, BLAs, MAAs).
- Ensure compliance with FDA/EU medical device and combination product regulations and standards (ISO 14971, ISO 13485, EU MDR).
- Identify technical/program risks and manage mitigation; manage vendors/partners.
- Manage multiple projects/priorities; support continuous improvement.
Requirements:
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or related field.
- 8+ years in combination product or medical device development (concept to commercialization/lifecycle).
- Demonstrated experience developing/commercializing prefilled syringes and autoinjectors.
- Strong knowledge of subcutaneous drug delivery systems; device design, systems engineering, materials, and manufacturing.
- Experience implementing design controls and risk management.
- Human factors/usability engineering experience (formative/summative; URRAs; plans/protocols/reports).
- In-depth knowledge of FDA/EU regulations, quality systems, and standards (ISO 14971, ISO 13485, EU MDR).
- Experience with device characterization and design verification testing.
- Experience contributing to device-related regulatory submissions.
- Proven vendor/partner management; excellent communication; ability to influence across functions; strong organization/project management.
Preferred:
- Advanced degree.
- Experience with biological drug products and primary packaging.
- cGMP process development, manufacturing controls, process risk assessments, and design transfer.
- Experience in fast-paced/high-growth biotech/pharma.
- Mentoring/technical leadership.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.
- Develop and execute strategies and technical roadmaps for drug-device combination product development.
- Provide technical leadership from concept through commercialization and lifecycle management.
- Lead human factors and usability engineering activities, including authoring/reviewing plans, usability risk assessments (URRAs), study protocols/reports, and design control documentation.
- Lead and support formative/summative human factors evaluations and interpret results.
- Provide technical expertise in drug delivery technologies, device design, systems engineering, design controls, risk management, materials, and manufacturing processes.
- Lead development of prefilled syringes, autoinjectors, and other drug delivery systems.
- Partner cross-functionally (Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, Regulatory Affairs).
- Oversee external testing laboratories and author/review protocols and reports.
- Establish/maintain design control processes and Design History File (DHF) documentation.
- Support design transfer (process risk assessments, specifications, control strategies, statistical evaluation).
- Author/review combination product sections of regulatory submissions (INDs, IMPDs, BLAs, MAAs).
- Ensure compliance with FDA/EU medical device and combination product regulations and standards (ISO 14971, ISO 13485, EU MDR).
- Identify technical/program risks and manage mitigation; manage vendors/partners.
- Manage multiple projects/priorities; support continuous improvement.
Requirements:
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or related field.
- 8+ years in combination product or medical device development (concept to commercialization/lifecycle).
- Demonstrated experience developing/commercializing prefilled syringes and autoinjectors.
- Strong knowledge of subcutaneous drug delivery systems; device design, systems engineering, materials, and manufacturing.
- Experience implementing design controls and risk management.
- Human factors/usability engineering experience (formative/summative; URRAs; plans/protocols/reports).
- In-depth knowledge of FDA/EU regulations, quality systems, and standards (ISO 14971, ISO 13485, EU MDR).
- Experience with device characterization and design verification testing.
- Experience contributing to device-related regulatory submissions.
- Proven vendor/partner management; excellent communication; ability to influence across functions; strong organization/project management.
Preferred:
- Advanced degree.
- Experience with biological drug products and primary packaging.
- cGMP process development, manufacturing controls, process risk assessments, and design transfer.
- Experience in fast-paced/high-growth biotech/pharma.
- Mentoring/technical leadership.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.