New Product Development Engineer

3 weeks ago


Santa Clara, United States Kelly Full time

Kelly Services is actively searching for a Design Quality Engineer - New Product Development supporting the system quality engineering team for a 6+ month onsite engagement with one of our global clients located in Santa Clara, California.


Pay rate starts at: $50/hour + benefits + PTO

Fully onsite role

Term: 6 months with potential for an additional term


Purpose: The main driver is to hire quality engineers to help support the sub-system quality engineering team.


Responsibilities:

Support review of design verification protocols/reports, test method validation, test fixture design review/qualification.

Support Installation qualification of non-product software, test equipment.

Support risk management activities for system-level hazard analysis, use FMEA.

Support cross-functional collaboration on key quality process such as defect tracking/resolution, test execution, etc.

Support review of build protocol / build report, DHR and configuration change and its impact on Design Verification reports.

Support review of Design Control deliverables.


Requirements:

Bachelor's degree

New product development experience

GD&T knowledge (preferred)

5 years experience in design quality engineering and new product development.

Experience in medical device industry or other highly regulated field.

Experience with medical electrical-mechanical systems.

Knowledge of FDA requirements for design control of medical devices.

Understanding of Risk Management process per ISO 14971



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