Lead Drug-Device Systems Engineer (Prefilled Syringes)

Arrowhead Pharmaceuticals; Los Angeles (CA); Sur place; USD 150 000 - 230 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Excellent benefits package

Résumé du poste

Arrowhead Pharmaceuticals is seeking a highly experienced Engineer to lead drug-device combination product development from concept to commercialization and lifecycle management. You will drive strategy, design controls, risk management, and cross-functional execution with teams across Packaging, Manufacturing, Clinical Development, and Regulatory Affairs.

The role requires deep expertise in drug delivery systems, human factors engineering, design history files, and regulatory submissions.

Qualifications

• Bachelor's degree in biomedical or related engineering field required.
• 8+ years in combination product or medical device development from concept to commercialization.
• Experience with prefilled syringes and autoinjectors.
• Strong knowledge of subcutaneous delivery systems and manufacturing processes.
• Experience implementing design controls and risk management.
• Regulatory knowledge: FDA/EU medical device requirements (ISO 14971, ISO 13485, EU MDR).
• Ability to lead human factors activities and usability work.
• Proven collaboration across functions and external partners.

Responsabilités

• Develop strategies and roadmaps for drug-device programs.
• Provide technical leadership from concept through lifecycle management.
• Lead human factors and usability engineering activities and URRAs.
• Create and review design control documentation and DHF.
• Oversee external testing labs and vendor partnerships.
• Support regulatory submissions and process transfers.
• Ensure compliance with regulatory standards and quality systems.
• Manage multiple projects with timelines and budgets.

Connaissances

Technical leadership

Human factors engineering

Regulatory understanding

Project management

Cross-functional collaboration

Effective communication

Formation

Bachelor's degree in Biomedical/Mechanical/Pharmaceutical sciences

Advanced degree preferred

Description du poste

Arrowhead Pharmaceuticals is seeking a highly experienced Engineer to lead drug-device combination product development from concept to commercialization and lifecycle management. You will drive strategy, design controls, risk management, and cross-functional execution with teams across Packaging, Manufacturing, Clinical Development, and Regulatory Affairs.

The role requires deep expertise in drug delivery systems, human factors engineering, design history files, and regulatory submissions.