Orange County Metro Area, CA
The Senior Engineer will work on a biologics pre-filled syringe product. Her/his role on the team will be to guide the team with the design controls deliverables by reviewing the plans, protocols, reports, etc., and providing input.
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 (MUST HAVE)
Pre-filled syringes experience (MUST HAVE)
Experience with PFS with biologics (filling, packaging, sterilization) (MUST HAVE)
Expertise in medical device development (MUST HAVE)
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
Ability to comprehend and apply principles of advanced math and statistical theory (to include t-tests, f-tests, tolerance limits, etc.).
Knowledge of GMPs, ISO standards related to the pre-filled syringes development and manufacture.
Ability to effectively interact with CMOs to transfer designs into production.
Ability to travel at least 10% of time
Main Areas of Responsibilities:
Contributes to the completion of major programs and projects, guides the successful completion of minor programs
Provides technical assessments for business development decisions as needed. Provides technical solutions to a wide range of difficult and complex problems.
Providing general and technical guidance to the team, as needed.
Collects, organizes and analyzes technical information to support the development and design of products. Performs technical and statistical analyses in the form of written reports.
Identifies technical opportunities and provides analysis to demonstrate concept while meeting key specifications
Provides support to other departments as necessary to support production or product development
B.S. Engineering or other related discipline with 7+ years of experience OR M.S. with 5+ years of experience. Advanced degree desired.