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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, Danville , R&D Staff Engineer - Packaging , Manufacturing , Fremont, CA, California


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