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Engineer - Combination Device development

Company: IDC Technologies
Location: Irvine
Posted on: November 23, 2020

Job Description:

Engineer - Combination Device development Irvine, CA 92612 Contract Job Description Design Controls experience - from early stages to validation and transfer (MUST HAVE) bull Pre-filled syringes experience (MUST HAVE) bull Experience with PFS with biologics (filling, packaging, sterilization) (MUST HAVE) bull Expertise in medical device development (MUST HAVE) bull 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. bull Complete understanding and application of technical principles, theories, and concepts in the field of parenteral delivery. bull Experience working in a general engineering laboratory setting related to medical device development bull Ability to comprehend and apply principles of advanced math and statistical theory (to include t-tests, f-tests, tolerance limits, etc.). bull Knowledge of GMPs, ISO standards related to the pre-filled syringes development and manufacture. bull Ability to effectively interact with CMOs to transfer designs into production. bull Ability to travel at least 10 of time Contributes to the completion of major programs and projects, guides the successful completion of minor programs bull Provides technical assessments for business development decisions as needed. Provides technical solutions to a wide range of difficult and complex problems. bull Providing general and technical guidance to the team, as needed. bull 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. bull Identifies technical opportunities and provides analysis to demonstrate concept while meeting key specifications bull Provides support to other departments as necessary to support production or product development Bachelors Masters in Mechanical Engineering

Keywords: IDC Technologies, Irvine , Engineer - Combination Device development, Engineering , Irvine, California

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