SUMMARY:
Responsible for designing devices and custom
equipment related to MicroCor, a microstructure
technology for delivering small and large
molecular weight drugs through the skin. .
Responsibilities/Duties:
§ Conceive, plan, develop and lead process and
equipment development, translating device,
equipment and process concepts into repeatable, cost effective methods.
§ Perform exploratory research.
§ Observe and investigate problems, analyze,
hypothesize mechanisms that help identify the root cause.
§ Propose, design and conduct experiments to obtain mechanistic understanding.
§ Design plastic and metal micro-parts and
assemblies that meet the performance, budget,
quality and regulatory requirements.
§ Review and convey findings to the technical organization or management.
§ Identify the needs and build required measurement systems.
§ Lead in material selection and testing.
§ Lead the development of equipment
specifications and qualifications (URS, FAT, IQ, OQ and PQ protocols).
§ Develop the overall process flow and write
methods and create in-process drawings.
§ Lead development of the aseptic process and environmental control.
§ Initiate patent applications.
§ Evaluate suppliers.
§ Use innovative approaches to problem-solving.
§ Supervise junior staff.
Qualification / Experience Requirements:
§ MS/PhD in ME/EE.
§ 5+ years of experience developing multidisciplinary technology.
§ High level of skill and expertise and proven
track record of designing small complex injection
molded plastic parts and assemblies.
§ Experience of having led the design process
complying with design control and phase gate approach.
§Hands on ability to lead projects and
demonstrated success in taking ownership of
complex process development projects and
achieving timely closures that meet the requirements.
§A strong core engineering knowledge that
includes engineering mechanics, fluid mechanics,
measurement systems, fixture design, differential
equations and control systems theory, Finite
Element Modeling, Statistics and DOE.
§ Proficiency with programming and working with
software such as Comsol, Matlab, Labview, Statgraphics etc.
§Understanding of drug/device development
process, design space mapping, risk analysis and
formal team based problem solving techniques.
§Excellent written and verbal communication
skills as well as excellent interpersonal skills.
Ashutosh Shastry, Ph.D.
Director, Engineering
Corium International, Inc.
235 Constitution Drive,
Menlo Park, CA 94025
<mailto:ashutoshs_at_coriumintl.com>ashutoshs_at_coriumintl.com
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Received on 2013-01-30 16:57:15