Engineer, Device Engineering
Arrowhead Pharmaceuticals
August 29, 2026
On-site
Los Angeles, CA
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/usability engineering; author/review plans, URRAs, protocols, reports, and design control documentation.
- Lead formative and summative usability evaluations and interpret results.
- Provide 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.
- Collaborate cross-functionally (Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, Regulatory Affairs).
- Oversee external testing laboratories (device characterization, design verification); author/review protocols and reports.
- Establish/maintain design control processes and DHF documentation; support design transfer (risk assessments, specs, control strategies, statistical evaluation).
- Author/review combination product regulatory submission sections (INDs, IMPDs, BLAs, MAAs).
- Ensure compliance with FDA/EU medical device and combination product regulations and standards (ISO 14971, ISO 13485, EU MDR).
- Identify risks, develop mitigations, manage vendors/partners, and 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).
- Experience developing and 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 (plans, URRAs, formative/summative evaluations, reports).
- In-depth FDA/EU regulations and quality systems/standards (ISO 14971, ISO 13485, EU MDR).
- Experience overseeing device characterization/design verification testing; authoring device regulatory sections.
- Proven vendor management; excellent communication; strong collaboration, organization, and project management.
Preferred:
- Advanced degree.
- Experience with biological drug products/primary packaging.
- cGMP process development, manufacturing controls, process risk assessments, and design transfer.
- Fast-paced/high-growth biotech/pharma experience.
- Mentoring/technical leadership experience.
- 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/usability engineering; author/review plans, URRAs, protocols, reports, and design control documentation.
- Lead formative and summative usability evaluations and interpret results.
- Provide 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.
- Collaborate cross-functionally (Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, Regulatory Affairs).
- Oversee external testing laboratories (device characterization, design verification); author/review protocols and reports.
- Establish/maintain design control processes and DHF documentation; support design transfer (risk assessments, specs, control strategies, statistical evaluation).
- Author/review combination product regulatory submission sections (INDs, IMPDs, BLAs, MAAs).
- Ensure compliance with FDA/EU medical device and combination product regulations and standards (ISO 14971, ISO 13485, EU MDR).
- Identify risks, develop mitigations, manage vendors/partners, and 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).
- Experience developing and 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 (plans, URRAs, formative/summative evaluations, reports).
- In-depth FDA/EU regulations and quality systems/standards (ISO 14971, ISO 13485, EU MDR).
- Experience overseeing device characterization/design verification testing; authoring device regulatory sections.
- Proven vendor management; excellent communication; strong collaboration, organization, and project management.
Preferred:
- Advanced degree.
- Experience with biological drug products/primary packaging.
- cGMP process development, manufacturing controls, process risk assessments, and design transfer.
- Fast-paced/high-growth biotech/pharma experience.
- Mentoring/technical leadership experience.