R&D Staff Engineer - Packaging
Company: Stryker Corporation
Location: Fremont, CA
Posted on: August 15, 2018
Job Description:
R&D Staff Engineer - Packaging for Stryker Corporation in
Fremont, CA to develop packaging and labeling components utilizing experience
and knowledge of technology, products, materials, processes,
equipment and industry standards, including EN ISO 11607, American Society for
Testing and Materials (ASTM) and International Safe Transit Association
(ISTA). Navigate medical device design control process to convert
marketing requirements for packaging and labeling into robust and creative
designs. Develop and verify design requirements and specifications.
Interface with Physicians and Cath Lab personnel to obtain feedback on concepts
and performance of packaging components. Apply knowledge of common
packaging and labeling materials, processes, testing and design approaches
for medical device packaging and make sound design recommendations.
Provide input into the Design Failure Mode and Effect Analysis (DFMEA)
and Process Failure Mode Effects Analysis (PFMEA). Compile and analyze test
data to write reports and establish technical specifications for
designing and modifying packaging components processes and materials. Work
cooperatively with process development, quality, manufacturing, regulatory,
clinical, and marketing to implement packaging and labeling components.
Requires: Bachelor's degree or foreign education equivalent in Mechanical,
Materials or Industrial Engineering, or Packaging Science plus five (5)
years of experience developing medical device packaging and labeling
or, alternatively, a Master's degree and three years of experience
as noted above. Specific skills/other requirements (quantitative
experience requirements not applicable to this section): leading packaging
and labeling design and validation for new product development of
class I, II and II medical devices, including labeling per ISO 13845, EN ISO
11607, EN 1041 and ISO 15223; packaging using sterile barrier sealing
equipment and processes and design and statistical analysis tools, including
SolidWorks, Adobe Illustrator or Minitab; utilizing medical device design
control and regulations for Food and Drug Administration (FDA) or CE
(Conformité Européene) approval; utilizing American Society for Testing and
Materials (ASTM) and International Safe Transit Association (ISTA) medical
device packaging testing standards for class I, II and III medical
devices for distribution simulation, packaging integrity and material
testing; conducting root cause analysis using Lean Six Sigma tools for
packaging or labeling process failures and leading resolution on
non-conformance, corrective and preventive action (CAPA), quality plans and other
compliance efforts; and developing robust processes for manual packaging
assembly and support audits by regulatory bodies. Submit resume to Stryker
Corporation, Nicole K. Benn, 1901 Romence Road Parkway, Portage, Michigan
49002. Reference Position Number: 141.
Keywords: Stryker Corporation, Fremont , R&D Staff Engineer - Packaging , Manufacturing , Fremont, CA, California