Strategic Lead, Combination Product Development

Otsuka Pharmaceutical Co., Ltd.; United States; Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) match

Paid holidays and paid time off

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks an experienced Device Development professional in the United States. The role focuses on combination products and drug-delivery devices, managing design history files and technical dossiers across platforms.

The candidate will coordinate risk assessments, human factors studies, and the creation of specifications, design controls, and technical reports. Travel up to 15–20% may be required.

Qualifications

• 5-8 years of experience in Pharmaceuticals, Medical Devices, Biotechnology, or related industries.
• Deep understanding of device verification, testing, validation, QA, and regulatory requirements for devices.

Responsibilities

• Manage design history files and support authoring of technical dossiers for combination product and device projects.
• Facilitate risk assessments and coordinate human factors usability studies.
• Create and manage product and component specifications, design controls, engineering protocols, and technical reports.
• Present findings to project teams and management; coordinate external resources in a matrix organization.
• Develop project plans and manage cross-functional teams including third-party resources; execute HF engineering & usability activities.

Skills

Device development

Quality systems (CFR 820/ISO 13485)

Human factors engineering

Risk management (ISO 14971)

Technical writing

Presentation skills

Project leadership

Education

Bachelor's degree in engineering

Masters degree preferred

Tools

MSProject

MSOffice

Job description

Otsuka Pharmaceutical Co., Ltd. seeks an experienced Device Development professional in the United States. The role focuses on combination products and drug-delivery devices, managing design history files and technical dossiers across platforms.

The candidate will coordinate risk assessments, human factors studies, and the creation of specifications, design controls, and technical reports. Travel up to 15–20% may be required.