Principal Engineer, Device Development

Job Summary

A company is looking for a Principal Engineer, Drug Device Combination Product Development.

Key Responsibilities

• Develop and execute a strategic roadmap for biologic/device combination product development
• Lead human factors development activities and ensure usability and patient safety
• Collaborate with cross-functional teams to ensure successful project delivery and compliance with regulatory standards

Required Qualifications

• Bachelor's degree in biomedical engineering, mechanical engineering, pharmaceutical sciences, or related field; advanced degree preferred
• Over 8 years of experience in drug product device development with a proven track record of successful product launches
• Background in leading human factors evaluations and knowledge of regulatory requirements
• Extensive experience with prefilled syringes and autoinjectors, and managing design control processes
• In-depth knowledge of FDA and EU medical device regulations and quality systems