Engineer - Combination Device development
Company: IDC Technologies
Location: Orange
Posted on: November 22, 2020
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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, Orange , Engineer - Combination Device development, Other , Orange, California
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