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, Mountain View , Senior Electrical Quality Engineer, Advanced, Manufacturing , San Jose, CA, California