Alex Saegert
With over 20 years solving product problems and developing breakthrough technologies the automotive, alternative energy, and medical device industries, I’ve worked with companies large and small, on technology at all maturity levels.
Studying the tools used by industry heavyweights like Ford and Daimler (Mercedes-Benz) to assess and develop new technologies, I’ve applied those methods to the development demands of industries like nuclear power, vehicle safety and medical devices, and technology-intensive industries like hydrogen and alternative energy.
As a Senior member of the American Society for Quality, (ASQ), I hold designations as Certified Reliability Engineer (CRE), Certified Supplier Quality Professional (CSQP). I also hold a specialized ASQ credential recognizing expertise in Risk Management.
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Industry-appropriate Technology Readiness Level (TRL) Assessment, Technology Maturation Planning
Medical Devices: Design Quality Assurance, Risk Management, Human Factors, and Post-Market Surveillance
PEM Hydrogen Fuel Cells: Durability Testing, Life Data Analysis (Weibull, ALT), Design for Reliability,
Cryogenic Components: Design Considerations, Accelerated Durability Test Design, Data and Failure Analysis
Prototype Fleet Management: Reliability, Availability, and Maintenance (RAMs) planning, and growth
Training and Education: Robust Design, Risk Analysis, FMEAs, Human Factors, Usability Analysis, Investigations
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Medical Device Quality Management System Design and Development (USFDA 21CFR Part 820; ISO13485)
Medical Device Design Quality Assurance, Design History File (DHF) creation, completion, or remediation
Medical Device Risk Management: Risk Identification, Analysis, Documentation (ISO14971)
Medical Device Usability Engineering evaluation and Human Factors Analysis (IEC/ISO62366)
Hydrogen and Fuel Cell System Safety and Performance Analyses (CSA FC1 / CSA C22.2 No. 62282)
Safety - Related system analysis, ASIL determination, safety-related functional requirements (ISO26262)
Preparation of FMEAs using AIAG-VDA technique; Functional Analysis and Robust Design Techniques,
Design for Reliability (DFR), specification of design requirements, verification test design and analysis
Lifetime data analysis, Weibull analysis, warranty estimation, and warranty cost analysis
Maintainability and Availability analysis, Reliability-Centered Maintenance (RCM)
Reliability / Risk Management Software Package Operation (Reliasoft, Relyence, APIS IQ-RM)
Reliability Growth program planning and management
Design and Administration of Failure Reporting, Analysis and Corrective Action (FRACAs) Systems
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Product Development Planning and Knowledge Management (Product Lifecycle Management Implementation)
Cross - functional leadership facilitation and mentorship
Reliability planning, management, and documentation (Hazard Analysis, FMEA, Verification and Validation)
Extensive Root Cause Investigation and Corrective Action experience
Quantitative Accelerated Test Design and Planning (Time Compression, Elevated Stress, S-N, Step Stress Tests)
Requirements Capture / Functional Analysis / Trade-off Analysis (System Engineering, QFD, Pugh Charts)
Robust Engineering Design (Tolerance analysis, Tolerance Stack-up, Design for Six-Sigma)
Supplier Selection Auditing, ‘Make-or-Buy’ analysis, Production Part Approval Process (PPAP, IQ / OQ / PQ)
Accreditations
Association of Professional Engineers and Geoscientists of Alberta (APEGA) Permit to Practice ID 15829
Association of Professional Engineers and Geoscientists of Alberta
Association of Professional Engineers and Geoscientists of British Columbia
