Position Summary

We are seeking a Combination Product Development Expert to support the development of drug-device combination products. This role is responsible for managing product design, risk management, and regulatory documentation. The position will work closely with internal teams and external partners to ensure products are safe, effective, and compliant.

Reporting Structure

This role reports to the Executive Director, External R&D and works with Quality, Regulatory, Clinical, Supply Chain, and external design firms, manufacturers, and suppliers.

Key Responsibilities

• Support the design and development of drug-device combination products using design control processes
• Prepare, review, and maintain Design History Files (DHF) and risk management documentation
• Work with external partners to review product designs and development progress
• Provide technical support for combination products such as injectors, inhalers, transdermal systems, and infusion devices
• Ensure documentation meets regulatory and quality requirements
• Support product risk assessments, complaint investigations, and product improvements
• Partner with Quality and other teams to maintain compliant product files
• Stay current with regulatory requirements and industry standards

Qualifications

• BS or MS in Mechanical Engineering, Chemical Engineering, or related field
• 5–7 years of experience developing drug-device combination products
• Injectables or autoinjectors experience highly preferred
• Experience with design controls and risk management
• Experience with Design History Files (DHF) preferred
• Strong communication and technical writing skills
• Ability to work independently and work with cross-functional teams