Product Reliability Engineer, Project Leader Resume

SUMMARY:

Product Reliability Engineer with 15 years’ experience on hardware development, system and sub system levels requirements setting, product design verification and validation
Exceptional analytical and problem solving skills, low key and fact - based communication style, a natural positive agent in organization and project teams, cross functional team leader
Experienced with fast-pace & high volume consumer electronics, highly regulated medical devices; and high tech industries
ASQ certified Six Sigma Black Belt, MS Material Science and Engineering

SKILLS:

Problem solving skills: DMAIC, Six Sigma, FMEA, DoE (Design of Experiments), Gage R&R, SPC, DfR (Design for Reliability), RCA (Root Cause Analysis), Accelerated Life Testing (HALT/HASS)

Statistical Software: Minitab, JMP

Regulations: 21 CFR part 820 FDA

PROFESSIONAL EXPERIENCE:

Confidential

Product Reliability Engineer, Project Leader

Responsibilities:

Quality project leader on new product development of oral healthcare electro-mechanical consumer products, led all product quality related activities prior to and during launch including developing system and subsystem level requirements, setting quality and reliability targets, proper execution of the quality and reliability test plan, ensuring that product verification and validation efforts are completed prior to launch, and the product meets all user, functional, safety, regulatory and environmental requirements.

Confidential

Sr. Design Quality Engineer

Responsibilities:

End to end accountable for product design related CAPAs, including leading the root cause investigation, identifying and proposing the corrective and preventive actions, executing the verification and validations.
Interacting with the cross functional team across the entire product life chain from suppliers to first responders.
Steering the product team interactions to safeguard product quality, reliability and maintain regulatory compliance.
Guiding the development team to prioritize the activities with practicality in a timely manner.
External Defibrillator, Confidential Class III regulated environment

Confidential

Sr. Process Development Engineer

Responsibilities:

Responsible for fully developing and characterizing the manufacturing processes to optimize for robustness, cut the cost, maintain or improve reliability.
Interacting with manufacturers to ensure smooth process transfer.
Successfully transferred engineering concepts into manufactural process.
Technology advantage over major competitors by at least 8-10 years, with process improvement from Cpk <0.00 to > 4.0, cycle time reduction 40-80%.

Confidential

Process Development Engineer

Responsibilities:

Responsible for developing and optimizing the repairing / rejuvenation process for high temperature and high stressed parts, including metallurgical analysis (cross section, microstructural, SEM), material selection (alloys), defining heat treatment cycles.
Worked with suppliers globally for process qualification.
Gas Turbine, Jet Engine, High Tech

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