Senior Reliability Engineering Resume

SUMMARY

Continuous Improvement Product Test & Evaluation Technical/Proposal Writing FMEA(p/d) and Control Plan Development Lean Six Sigma Supplier Quality Control Technical Drawing & Specifications (GD&T/Y14.5) Quality Investigations & Improvements (CAPA) BOMs Capital Equipment/Projects Calibration/Inspection Manages Budgets & Schedules Test & Engineering Reports Life - Cycle management Analytical problem solving DOE/SPC Systems
Test & Integration Engineering EMC analyses Test plans & procedures ISO Quality Management Systems (ISO 9001/13485) Project Management Process Performance/Capability Ballistic/Mechanical/Environmental/Laboratory/Field Testing Fault Tree Analyses Industrial/Manufacturing Engineering Risk Management Post-Market Reliability Medical Universal Regulatory Compliance Bioincompatibility/Toxicity

PROFESSIONAL EXPERIENCE

Confidential

Senior Reliability Engineering

Responsibilities:

Senior Reliability Engineering with primary work responsibility on the Confidential - Confidential. As a minimum, duties include development/appraisal/research with Regulatory Compliance, CAPA, Risk Management Plan/Reports,
Essential Requirements Matrixes and Potential Adverse Events/Hazards associated with Post Market reliability of Confidential designed products - Implantable Pulse Generators, Leads, and Implantable Cardiac Defibrillators, etc. In addition, support various quality/reliability functions of Confidential ’s QMS (ISO 13485) and validation/verification testing, as required.

Confidential

Consultant

Responsibilities:

Consultant to various Government/regulated agencies and private industry for the development and management of quality/product test programs.
Technical writing activities and administration of various quality tools - quality planning, costs and assessment, LAT/UAT, basic and advanced statistical techniques and inspections, sampling principles (AQL, TQM, Lean Six Sigma, DOE/Taguchi) Working knowledge of problem solving tools - Process mapping, histograms, FMEA, Pareto Analyses, etc.

Confidential

Senior Principal Test Engineer

Responsibilities:

Design and oversee the conduct of ballistic, quality, mechanical, laboratory and environmental test programs and facilities for both US (Department of Army) and foreign Governments
Calibration and acquisition of specialized capital equipment
Generate cost/price technical analyses for program/sub-contracted test activities
Administer and manage multi-million dollar cost accounts/budgets and sub-contracts
Technical writing, develop and maintain technical manuals, procedures, SOP/DOP, test plans
Cost estimating/budgeting for all R&D/production test proposals and contracts
Generate in-family analyses, SPC, DOE, FMEA, and/or Taguchi studies
Technical test liaison with internal/external customers