Engineer, Device Engineering
Arrowhead Pharmaceuticals
August 29, 2026
Remote friendly (Madison, WI)
United States
Operations
Responsibilities:
- Develop and execute strategies and technical roadmaps for drug-device combination product development.
- Provide technical leadership for combination product development from concept through commercialization and lifecycle management.
- Lead human factors and usability engineering activities; author/review plans, URRAs, study protocols/reports, and design control documentation.
- Lead formative and summative human factors 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; 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 INDs, IMPDs, BLAs, and MAAs.
- Ensure compliance with FDA/EU medical device & combination product regulations and standards (ISO 14971, ISO 13485, EU MDR).
- Identify risks, develop mitigations, and communicate recommendations; manage vendors/partners.
Requirements:
- BS in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or related field.
- 8+ years’ experience in combination product or medical device development (concept through commercialization/lifecycle).
- Experience developing and commercializing prefilled syringes and autoinjectors.
- Knowledge of subcutaneous drug delivery systems, device design, systems engineering, materials, and manufacturing.
- Design controls and risk management experience.
- Human factors/usability engineering experience (formative/summative, URRAs, plans/protocols/reports).
- Knowledge of FDA/EU regulations, quality systems, and standards (ISO 14971/13485, EU MDR).
- Experience with device characterization/design verification testing; regulatory submission contributions.
- Vendor management; excellent written/verbal communication; 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.
- Fast-paced biotechnology/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 for combination product development from concept through commercialization and lifecycle management.
- Lead human factors and usability engineering activities; author/review plans, URRAs, study protocols/reports, and design control documentation.
- Lead formative and summative human factors 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; 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 INDs, IMPDs, BLAs, and MAAs.
- Ensure compliance with FDA/EU medical device & combination product regulations and standards (ISO 14971, ISO 13485, EU MDR).
- Identify risks, develop mitigations, and communicate recommendations; manage vendors/partners.
Requirements:
- BS in Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or related field.
- 8+ years’ experience in combination product or medical device development (concept through commercialization/lifecycle).
- Experience developing and commercializing prefilled syringes and autoinjectors.
- Knowledge of subcutaneous drug delivery systems, device design, systems engineering, materials, and manufacturing.
- Design controls and risk management experience.
- Human factors/usability engineering experience (formative/summative, URRAs, plans/protocols/reports).
- Knowledge of FDA/EU regulations, quality systems, and standards (ISO 14971/13485, EU MDR).
- Experience with device characterization/design verification testing; regulatory submission contributions.
- Vendor management; excellent written/verbal communication; 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.
- Fast-paced biotechnology/pharma experience; mentoring/technical leadership.
Application instructions:
- Candidates must have current, valid authorization to work in the country where the role is located.