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Senior Electrical Quality Engineer, Advanced

Company: Stryker Corporation
Location: San Jose, CA
Posted on: April 24, 2018

Job Description:

Senior Electrical Quality Engineer, Advanced for Stryker Corporation in San

Jose, CA to develop, apply, revise, and maintain quality standards for the

new product development process. Influence full design intent, including

design quality and material selection. Perform Design Failure Mode and

Effect Analysis (DFMEA) analysis to identify weaknesses in components.

Author Risk Management Files for new products, including identification of

hazards and harms, and ensuring risk control measures are identified.

Collaborate with the design team in the lab experimenting with prototypes

to identify issues and determine root causes. Identify Critical Quality

Attributes and turn them into inspection criteria. Help define acceptance

activities and inspection of components and assemblies. Define process

validation. Influence design based on knowledge of operating room workflow.

Ensure that defined user needs and design inputs are complete and accurate.

Participate in design validation, design verification and design

experimentation. Define verification and validation protocols. Define

customer preference testing and limited launch parameters. Organize medical

risk management boards. Visit clinical facilities and health care providers

(HCP) to gather data to further develop and improve clinical knowledge, use

cases, and potential applications for medical devices. Conduct post-launch

monitoring of newly launched products and incorporate lessons learned in

future products. Fulfill all assigned design history file (DHF)

deliverables. Participate in minor division mergers and acquisitions.

Participate in Make vs. Buy Decision and in supplier selection and audit.

Develop statistical process controls and analyze data. Optimize operating

parameters. Analyze and interpret engineering test data collected during

new device testing. Liaise with multiple departments and teams, including

R&D, Manufacturing and Quality, vendors and senior managers to ensure

specific cost, time and or regulatory standards are met. Requires:

Bachelor's degree or foreign education equivalent in Electrical Engineering

plus two (2) years of experience developing, applying, revising, and

maintaining quality standards for new product development processes.

Specific skills/other requirements (quantitative experience requirements

not applicable to this section): reading and interpreting blueprint and

engineering schematics to ensure optimal component and sub-assembly design

and identify critical quality attributes for process validation; performing

design control, verification and validation testing, including use of 21

CFR 820 and ISO 13485; performing electromechanical product development of

medical devices or electrical designs from concept to production; testing

printed circuit board assemblies and electrical components; and providing

usability and use case feedback to design products to meet surgeon and

operating room needs while improving workflow efficiencies. Submit resume

to Stryker Corporation, Nicole K. Benn, 1901 Romence Road Parkway, Portage,

Michigan 49002. Reference Position Number: 000098.

Keywords: Stryker Corporation, Milpitas , Senior Electrical Quality Engineer, Advanced, Manufacturing , San Jose, CA, California


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