Job Description :
Job Title: Sr. Engineer - Combination Device development Location: Irvine, CA?? Duration: Long term Job Description: -Combination devices design and development -6 to 10 years of experience -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 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