Engineer, Device Engineering
Arrowhead Pharmaceuticals
August 07, 2026
Remote friendly (Madison, WI)
United States
Operations
Responsibilities:
- Develop and execute strategies/roadmaps for drug-device combination product programs.
- 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/summative human factors evaluations and interpret results.
- Provide technical expertise in drug delivery technologies, device/system 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; 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 (IND/IMPD/BLA/MAA).
- Ensure compliance with FDA/EU requirements and standards (ISO 14971, ISO 13485, EU MDR); manage risks and vendors.
Requirements:
- BS in Biomedical/Mechanical Engineering, Pharmaceutical Sciences, or related.
- 8+ years in combination product/medical device development; concept-to-commercialization/lifecycle.
- Experience commercializing prefilled syringes and autoinjectors.
- Knowledge of subcutaneous delivery systems, device design, systems engineering, materials, manufacturing.
- Experience with design controls, risk management, human factors/usability engineering.
- Knowledge of FDA/EU regulations/quality systems (ISO 14971, ISO 13485, EU MDR).
- Experience with device characterization/design verification testing and device regulatory submission content.
- Strong communication, cross-functional influence, and project management.
Preferred:
- Advanced degree.
- Experience with biological drug products/primary packaging.
- cGMP process development, manufacturing controls, process risk assessments, design transfer.
- Fast-paced biotech/pharma experience; mentoring/technical leadership.
Compensation/Benefits:
- Wisconsin pay range: $120,000–$145,000; California pay range: $135,000–$155,000.
- Competitive salaries and an excellent benefit package.
Application instructions:
- Candidates must have current, valid authorization to work in the country where the role is located.
- Develop and execute strategies/roadmaps for drug-device combination product programs.
- 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/summative human factors evaluations and interpret results.
- Provide technical expertise in drug delivery technologies, device/system 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; 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 (IND/IMPD/BLA/MAA).
- Ensure compliance with FDA/EU requirements and standards (ISO 14971, ISO 13485, EU MDR); manage risks and vendors.
Requirements:
- BS in Biomedical/Mechanical Engineering, Pharmaceutical Sciences, or related.
- 8+ years in combination product/medical device development; concept-to-commercialization/lifecycle.
- Experience commercializing prefilled syringes and autoinjectors.
- Knowledge of subcutaneous delivery systems, device design, systems engineering, materials, manufacturing.
- Experience with design controls, risk management, human factors/usability engineering.
- Knowledge of FDA/EU regulations/quality systems (ISO 14971, ISO 13485, EU MDR).
- Experience with device characterization/design verification testing and device regulatory submission content.
- Strong communication, cross-functional influence, and project management.
Preferred:
- Advanced degree.
- Experience with biological drug products/primary packaging.
- cGMP process development, manufacturing controls, process risk assessments, design transfer.
- Fast-paced biotech/pharma experience; mentoring/technical leadership.
Compensation/Benefits:
- Wisconsin pay range: $120,000–$145,000; California pay range: $135,000–$155,000.
- Competitive salaries and an excellent benefit package.
Application instructions:
- Candidates must have current, valid authorization to work in the country where the role is located.