Reliability Engineer Senior Principal

PhD in Reliability Engineering Strong experience with Root Cause Failure Analysis, Equipment Criticality Ranking, preventive maintenance (PM) and predictive maintenance (PdM) optimization, and Failure Modes and Effects Analysis. Excellent experience with process automation systems. Strong experience of Current Good Manufacturing Practices (part of GxP). Excellent oral and written communication skills. Working knowledge of MS Excel. Exceptional ca[ability to manage complex issues and foster consensus among teams. Excellent experience in the pharmaceutical sector. Proficiency in technical writing and document reviews. Exceptional experience with contemporary technologies and best aseptic practices. Proactive approach to promoting safety within the workplace.NASA recognizes my achievement in Risk Engineering and Management, both interdepartmental and cross-functional, Strong writing abilities and attention to detail.

●IEC 62304, FDA guidance, IEEE standards

●Weibull DOORS. Attack Tree, U.S. Citizen

●FMEA, DFMEA, PFMEA, FTA, STPA, etc

●Isograph, Relex, Medini Analyze, Markov

●UL 4600, Six Sigma, Problem Solving,

●World’s first book on Risk Engineering of AI

●9 Books Published related to Functional Safety

●CAFTA, Reliasoft, APIS IQ. PD/PdM, GxP

●Diagnostic Coverage Analysis (DCA), FMEDA

●Physics-of-Failure, Cameo

●Crow-AMSAA (Growth Model), Cybersecurity

●Safety Of The Intended Functionality (SOTIF)

PROFESSIONAL EXPERIENCE OVER THE LAST 30 YEARS

Capgemini Senior Principal FuSA Analyst 09/2021 – Present

Farmington Hills, Michigan.

Capgemini is a global leader in consulting, technology services and digital transformation, harnessing the power of technology.

Senior Principal Reliability Engineer of General Dynamics Land Systems Inc for Johnson & Johnson

Evaluate PM tasks to determine if they are truly adding value, potentially eliminating redundant tasks, adjusting intervals, and adding new, effective tasks.

Develop and maintain a site reliability program that uses data to focus on equipment, utility and maintenance upgrades

Coordinate maintenance and reliability engineering tasks, including the redesign, upkeep, and repair of utility systems, buildings, and equipment.

Lead moderately complex projects, effectively managing time and developing short-term plans.

Received the Wall of Fame award, the highest award of Capgemini.

Received Future Shaper awards twice. Once from Capgemini America CEO

Senior Principal Reliability Engineer for Novo Nordisk A/S

Provide engineering support for developing scopes of work, project execution plans, and engineering studies for equipment installation or modification.

Offer operational support, review preventive and corrective work orders, and manage technical writing and document reviews.

Ensure calibration compliance with Current Good Manufacturing Practices, contemporary technologies, and best aseptic practices.

Senior Principal Reliability Engineer for Roche Holding AG

Lead Cross-Functional Collaboration:.drive continuous improvement efforts, collaborate across multi-disciplinary teams, and provide technical expertise to ensure successful project outcomes.

Participate in Root Cause Failure Analysis investigations and update equipment reliability plans, collaborating with Production and Quality Team Leads.

Promote workplace safety by following site safety procedures and performing proactive safety assessments.

Actively participate in site and corporate initiatives, and serve as a liaison between quality, operations, and regulatory/compliance for timely closure of investigations.

Senior Principal Reliability Engineer for Eli Lilly and Co.

Lead Continuous Improvement Program.

Identify and drive opportunities for process improvement within the Hardware and Test Engineering functions to enhance efficiency, quality, clarity, and compliance.

Senior Principal Reliability Engineer for AbbVie Inc.

Serve as a resource for addressing and resolving issues of process and documentation.

Apply best practices from methodologies like DFSS (Design for Six Sigma) and an Agile mindset to all projects.

Review and remediate hardware design control documentation.

Senior Principal Reliability Engineer for Merck & Co.

Follow industry standard practices while creating the safety cases.

Create the following reports as part of the contract deliverables: Failure Analysis and Corrective Action Report (FACAR), Failure Summary and Analysis Report, FRACAS Report: Failure Analysis and Corrective Action Report, Safety Assessment Report (SAR): Safety & Health Hazard Assessment Report

Perform various hazard analyses including SHA, SSHA, PHA, FTA, FHA.

Develop and test hard-kill active protection systems, such as the Iron Curtain and Iron Fist.

Senior Principal Reliability Engineer for GENETWORx

Developing system and software requirements for the System-on-Chips (SoCs) and MCU platforms.

Determining Functional Safety market trends and safety requirements for Renesas solutions with an emphasis on software products; • Defining and consolidating Functional Safety Concepts, application cases, and requirements within an international team

Provide system/software application expertise to safety managers and software design teams with a strong customer-focused approach and excellent communication, presentation, and organizational abilities.

Through pre-sales and execution, support automotive customer engagements and internal/external security process/product audits.

Senior Principal Reliability Engineer for Admera Health

My work includes creating software for 360-degree situational awareness, autonomous threat tracking, and obstacle avoidance for various platforms,

To ascertain integrity levels, prepare risk approaches (such as Safety Integrity Levels, or SILs).

General Electric (GE) Healthcare 05/1995 – 09/2021

Grand Rapids, Michigan

Senior Principal Reliability Engineer(Member of Functional Safety Board)

Provide expertise in software, hardware, and FPGA design, as well as networking and RF platforms, to help companies develop MAPS-compliant products.

Develop overall software processes related to safety on various healthcare platforms.

Follow and implement MIL-STD 882E standards.

Verify software is proving out to hardware related to appropriate safety measures.

Analyze software code related to safety-critical components on a healthcare vehicle.

Assess criticality and Level of Rigor (LoR), including Software Criticality Indexes, in accordance with MIL-STD-882E, AOP-52, and the Joint Software System Safety Handbook (JSSSEH) as safety standards.

Coauthored a book on Risk Engineering for GE Edison Technical Leadership Program (TLP) on Functional Safety/Cybersecurity.

Served as Member of IEEE Reliability Society Risk Management Committee.

Professional EXPERIENCE (07/1985 to 05/1995)

EpicCare Ambulatory and GenoActKailos

Business Trips to Tecumseh, Brazil for developing healthcare electric vehicles (EV) and advance drive assist system (ADAS).

Research at Paul Scherrer Institute, Switzerland on healthcare electric vehicles (EV) and advance drive assist system (ADAS). with Delft University of Technology, The Netherlands.

Presented Software Safety Engineering Seminar in Delft University of Technology, The Netherlands.

Senior Research Fellowship in healthcare electric vehicles (EV) and advance drive assist system (ADAS). at Delft University of Technology, Netherlands.

Consultant to Austrian Aerospace Company / European Space Agency (ESA) on Hermes Software Safety.

Software Safety Engineering Expert, reviewing space power projects for International Atomic Energy Agency.

Worked on Siemens/KWU’s project on Low Temperature District Heating Softwares.

Worked with Germany’s Forschungszentrum Jülich on HTR-500

CERTIFICATIONS

●Certified Reliability Engineer (CRE), Certified by American Society for Quality (ASQ).

●Certified Six Sigma Master Black Belt, Certified by International Quality Federation (IQF).

●Certified Six Sigma Master Black Belt, Certified by General Electric Company (GE).

EDUCATION / TRAINING / CITIZENSHIP, etc.

●PhD, Reliability Engineering, University of Maryland, College Park, MD. Created and served as the first president of IEEE Reliability Society Student Chapter.

●M.S., Safety Engineering/System Safety, Tsinghua University, Beijing, China

●B.A., Energy Systems/Mechanical Engineering, Tsinghua University, Beijing, China.

●B.A., Safety Engineering/Engineering Physics, Tsinghua University, Beijing, China.

●GE Leadership Training - Presentation skills at GE, GE Corporate Education Center.

●Lean Manufacturing & Effective Program Management GE Corporate Education Center.

●Managerial Skills Development Course, GE Corporate Education Center

●Project Leadership Course – II & Project Leadership Course – I, GE Corporate Education Center.

●US Patent 10291156, Combined hybrid thermionic and thermoelectric generator, granted by United States Patent and Trademark Office on 2019-05-14

●US Patent 10679834, Hybrid solar generator, granted by United States Patent and Trademark Office on 2020-06-09.

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