Job Title
We are seeking a highly skilled and experienced engineering professional to support the development of innovative biologic/device combination products.
This critical role is responsible for developing and executing strategic roadmaps, aligning with overall objectives.
The ideal candidate will possess a deep understanding of drug delivery systems, human factors engineering, medical device regulations, and a proven track record of successful product development.
* Develop and execute a strategic roadmap for biologic/device combination product development.
* Lead human factors development activities to ensure usability and patient safety.
* Author and review human factors/usability engineering plans, risk management documentation, study protocols and reports, and supportive design control documentation.
* Collaborate with cross-functional teams to ensure successful project delivery.
* Provide technical leadership and expertise in drug delivery technologies, device design, design control, and manufacturing processes.
* Manage and prioritize multiple projects simultaneously, ensuring adherence to timelines and budgets.
* Ensure compliance with all relevant regulatory requirements throughout the product lifecycle.
Key Responsibilities:
* Prefilled syringe and autoinjector product development.
* Author relevant sections for regulatory submissions.
* Built and maintain strong relationships with key stakeholders.
* Support design transfer activities including process risk evaluation, process specifications, process control strategy, statistical evaluation for specifications.
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 formative and summative evaluations.
* Demonstrated knowledge of regulatory requirements and industry best practices.
* Experience with biological drug products and packaging development is a plus.
* In-depth knowledge of current FDA and EU medical device regulations and quality systems.