Snr Engineer - Device - Syringe Development
Orange County Metro Area, CA
- Strong design control experience and pre-filled syringe development experience. The successful candidate will have experience with biologics products, pre-filled syringes, unit operations of the PFS (filling, packaging, sterilization), testing of PFS, regulatory submission requirements.
- The candidate will join a team as a contributor to, and reviewer/approver of all design controls documentation.
- The Senior Engineer will work on a biologics pre-filled syringe product.
- Under minimal direction, the Senior Engineer will perform engineering duties associated with the design, research, and development of combination products. He/she review all development documentation generated in projects.
- The incumbent will also represent the organization as the prime technical contact on contracts and projects and interact with senior external personnel on significant technical matters, often requiring coordination between organizations.
The following listed requirements need to be met at a minimum level to be considered for the job:
Design Controls experience - from early stages to validation and transfer
- -filled syringes experience
Experience with PFS with biologics (filling, packaging, sterilization)
Expertise in medical device development
Demonstrated knowledge of research and development aspects from product concept to product launch, including design and process development, vendor communication, protocol creation, design, testing and documentation.
Complete understanding and application of technical principles, theories, and concepts in the field of parenteral delivery.
Experience working in a general engineering laboratory setting related to medical device development