Engineer, Device Engineering
Arrowhead Pharmaceuticals
August 07, 2026
Remote friendly (San Diego, 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 (formative and summative evaluations).
- Author/review human factors/usability plans, URRAs, study protocols/reports, and design control documentation.
- Provide expertise in drug delivery technologies, device design, systems engineering, design controls, risk management, materials, and manufacturing.
- Lead development of 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.
- Oversee external testing laboratories (device characterization/design verification).
- Establish/maintain design control processes and DHF documentation.
- Support design transfer (risk assessments, specifications, control strategies, statistical evaluation).
- Author/review combination product sections of INDs, IMPDs, BLAs, and MAAs.
- Ensure compliance with FDA/EU device and combination product regulations and standards (ISO 14971, ISO 13485, EU MDR).
- Identify technical/program risks, manage vendors/partners, and support continuous improvement.
Requirements:
- Bachelor’s in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or related.
- 8+ years’ experience in combination product or medical device development (end-to-end lifecycle).
- Demonstrated experience with prefilled syringes and autoinjectors.
- Strong knowledge of subcutaneous drug delivery, device design, systems engineering, materials, and manufacturing.
- Experience implementing design controls and risk management; leading human factors/usability engineering.
- In-depth knowledge of FDA/EU regulations and quality systems (ISO 14971, ISO 13485, EU MDR).
- Experience with device characterization/design verification testing and contributing to regulatory submissions.
- Strong communication, stakeholder influence, and project management.
Preferred:
- Advanced degree.
- Experience with biological drug products and primary packaging.
- cGMP process development, manufacturing controls, process risk assessments, design transfer.
- Fast-paced/high-growth biotech/pharma experience.
- Mentoring/technical leadership.
Application instructions:
- Candidates must have current, valid authorization to work in the country where the 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 (formative and summative evaluations).
- Author/review human factors/usability plans, URRAs, study protocols/reports, and design control documentation.
- Provide expertise in drug delivery technologies, device design, systems engineering, design controls, risk management, materials, and manufacturing.
- Lead development of 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.
- Oversee external testing laboratories (device characterization/design verification).
- Establish/maintain design control processes and DHF documentation.
- Support design transfer (risk assessments, specifications, control strategies, statistical evaluation).
- Author/review combination product sections of INDs, IMPDs, BLAs, and MAAs.
- Ensure compliance with FDA/EU device and combination product regulations and standards (ISO 14971, ISO 13485, EU MDR).
- Identify technical/program risks, manage vendors/partners, and support continuous improvement.
Requirements:
- Bachelor’s in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or related.
- 8+ years’ experience in combination product or medical device development (end-to-end lifecycle).
- Demonstrated experience with prefilled syringes and autoinjectors.
- Strong knowledge of subcutaneous drug delivery, device design, systems engineering, materials, and manufacturing.
- Experience implementing design controls and risk management; leading human factors/usability engineering.
- In-depth knowledge of FDA/EU regulations and quality systems (ISO 14971, ISO 13485, EU MDR).
- Experience with device characterization/design verification testing and contributing to regulatory submissions.
- Strong communication, stakeholder influence, and project management.
Preferred:
- Advanced degree.
- Experience with biological drug products and primary packaging.
- cGMP process development, manufacturing controls, process risk assessments, design transfer.
- Fast-paced/high-growth biotech/pharma experience.
- Mentoring/technical leadership.
Application instructions:
- Candidates must have current, valid authorization to work in the country where the role is located.