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Principal Scientist/Engineer
3 weeks ago
This is a highly skilled role that will lead the design, development and performance evaluation of drug-device combination products ensuring they meet regulatory and quality standards.
Responsibilities- Provide subject matter expertise for combination product development, planning and executing design verification and reliability strategies.
- Be the technical interface between drug product and device teams during combination product development, developing test methods and specifications for device functionality and product performance.
- Conduct material assessment of device components including biological evaluation, extractables profiling, and material certification.
- Provide technical support to manufacturing sites during filling and assembly process development, using statistical techniques for data analysis to inform design decision making.
- Lead support activities for external and internal audits and inspections.
- Master's degree in Science/Engineering.
- 7+ years' experience in pharmaceutical and/or medical device development.
- Working knowledge of design control requirements and ISO 13485.
- Experience in analytical method development and validation.
- Statistical technique application for data analysis.
- Regulatory submission writing and support experience.
- Excellent communication skills and ability to travel.
