Engineer, Device Engineering
Arrowhead Pharmaceuticals
August 29, 2026
Remote friendly (San Diego, CA)
United States
Operations
Responsibilities:
- Develop and execute strategies/technical roadmaps for drug-device combination product development.
- Provide technical leadership from concept through commercialization and lifecycle management.
- Lead human factors and usability engineering; author/review plans, URRAs, protocols, reports, and design control documentation.
- Lead formative/summative human factors evaluations.
- 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, Supply Chain, Commercial, Quality, Regulatory).
- Oversee external testing labs; 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 device & combination product regulations and standards (ISO 14971, ISO 13485, EU MDR).
- Identify risks, develop mitigation strategies, manage vendors/partners, and support continuous process improvement.
Requirements:
- BS in Biomedical/Mechanical Engineering, Pharmaceutical Sciences, or related field.
- 8+ years in combination product or medical device development (concept-to-commercialization/lifecycle).
- Experience developing/commercializing prefilled syringes and autoinjectors.
- Strong knowledge of subcutaneous drug delivery, device design, systems engineering, materials, and manufacturing.
- Demonstrated design controls and risk management.
- Human factors/usability engineering experience (plans, protocols, reports, URRAs).
- In-depth FDA/EU regulatory knowledge (ISO 14971, ISO 13485, EU MDR); device characterization/design verification testing; regulatory submission experience.
- Vendor management; excellent communication; ability to influence/collaborate; strong organization/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 this role is located.
- Develop and execute strategies/technical roadmaps for drug-device combination product development.
- Provide technical leadership from concept through commercialization and lifecycle management.
- Lead human factors and usability engineering; author/review plans, URRAs, protocols, reports, and design control documentation.
- Lead formative/summative human factors evaluations.
- 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, Supply Chain, Commercial, Quality, Regulatory).
- Oversee external testing labs; 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 device & combination product regulations and standards (ISO 14971, ISO 13485, EU MDR).
- Identify risks, develop mitigation strategies, manage vendors/partners, and support continuous process improvement.
Requirements:
- BS in Biomedical/Mechanical Engineering, Pharmaceutical Sciences, or related field.
- 8+ years in combination product or medical device development (concept-to-commercialization/lifecycle).
- Experience developing/commercializing prefilled syringes and autoinjectors.
- Strong knowledge of subcutaneous drug delivery, device design, systems engineering, materials, and manufacturing.
- Demonstrated design controls and risk management.
- Human factors/usability engineering experience (plans, protocols, reports, URRAs).
- In-depth FDA/EU regulatory knowledge (ISO 14971, ISO 13485, EU MDR); device characterization/design verification testing; regulatory submission experience.
- Vendor management; excellent communication; ability to influence/collaborate; strong organization/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 this role is located.