Senior Electrical Quality Engineer, Advanced
Company: Stryker Corporation
Location: San Jose, CA
Posted on: April 24, 2018
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, San Jose, Senior Electrical Quality Engineer, Advanced, Manufacturing, San Jose, CA, California
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