Resume of:

Abdellah Menikh,Post-doctoral, Ph.D, MS, BS

Contact:437-***-****

ady4zz@r.postjobfree.com

SUMMARY:

Sr Principal Systems Engineering Consultant with In-depth knowledge of medical device development life cycle, experience in medical instrument architecture, design, fluidic, microfluidic point of care, hemodialysis, biosensors (optical, electrochemical,), combination products, imaging, disposable cartridges, automation, clinical chemistry, sterilization, drug delivery, medical devices requirement management, specifications, validation/verification (V&V), technical risks, reliability testing, Risk management, Cyber security safety, FMEA, DFM,QFD, CAPA, process validation (IQ, PQ, OQ), embedded software development,, Minitab, and design for six sigma (DFSS), DOE, experience in ISO 13485, risk management 14971, electrical equipment 60601, code federal regulation 21CFR 820, 510K submission, and agile software development in regulated industry, knowledgeable/ experience with modeling, CAD/CAM, solving product design issues and ensuring overall design quality.

Comprehensive knowledge and practice in all aspects of R&D, complex systems engineering, product development and transforming theory and findings into commercialized technology. 20+ years of experience in medical devices delivering quality products

EXPERIENCE:

Epocal Inc (Ottawa ON) ( remote contract) Feb 2023- Present

Senior Principal Engineer Software Development

i. User needs specification, design, software verification and validation (V&V). Unite integration.

ii.Lead “software as a medical device” development life cycle based on IEC 62304 (Development planning, requirement analysis, architectural design, unit implementation and verification, integration testing, system testing and release).

iii.Developing human factors engineering plans for GUI

ECI Compliance, MA

Senior principal Systems Engineer (remote contract assignment): Medicinal infusion pump: Dec 2021- Dec 2022

Writing user needs and product requirement using DOORS 9.5 and MagicDraw

Generating test reports and writing SOP and processes

Gap assessment and risk management, provide recommendation on Product life cycle development

Helping the team understand the science and engineering of medical devices.

Maintain product requirement traceability from system level to its components

Lead GUI design, GUI requirements and reducing resource costs while maximizing GUI reusability

Supporting the execution of operating experience reviews, task analysis, human error analysis, making human factors design recommendation

Becton Dickinson, Andover, MA (remote contract assignment) : Glucose Infusion Pump Jan 2021 – Dec 2021

System Architecture Review, Risk Management, Analysis and feasibility for Medical Device, Risk Management, System Level modeling for hardware and software based products. Services provided to client handling Requirements Management and System Modeling abilities for Hardware and Software products.

Task 1) Support System Level requirement generation and organization for project

Analyze System requirements (Hand-held device and body worn device)

Review existing documentation including EU MDR

Conduct Gap analysis

Generate Plan to close out gaps.

Work with team to begin addressing gaps

Work intensively in reliability analysis and testing

Connectivity requirements generation and usability testing

Task 2) Support Requirement Management tool deployment

Test and provide recommendations on feasibility of using applicable tools.

Work with Requirement Management deployment team to ensure that Product Requirements are uploaded to selected tool(s).

work on usability and addressing human factor plan

Write human factor test plan and tests for internal and external users.

Task 3) Support System Architecture Review and Deployment

System architecture review and compilation (Hand-held device and body worn device)

Document generation for operational perspectives and design.

OmniSeq, Buffalo, NY (remote contract assignment) Mar 2021 –Dec 2021

As a Senior Principal IVD Systems Engineer, I worked closely with R&D teams to design, define, manage, and document systems consisting of laboratory developed tests for cancer diagnostics throughout the development lifecycle, as well as supporting FDA submissions within an IVD framework.

I collaborated with functional leaders in software, bioinformatics, assay development, lab automation, sequencing, and cancer screening to support design, integration and documentation from sample receipt to clinical report generation.

I took on the leadership role within the Systems engineering team to spearhead all regulatory aspects of technical projects, and optimized/integrated complex and multi-variate problems at the interface of laboratory automation, process engineering, molecular biology, regulatory and operations.

I provided influence and guidance to co-workers to integrate the QSR mindset into the day-to-day and built efficient workflows that enabled the team to navigate the regulatory environment while maintaining momentum.

Essential Duties and Responsibilities:

Lead and/or participate in system architecture and integration design, development, testing documentation and implementation.

Develop evaluation methods to analyze workflows, identify bottlenecks, benchmark process performance and develop solutions to improve efficiency, throughput, cost, and quality.

Ability to work with functional system owners to design and develop future proof, scalable and integrated systems from beginning to end of the clinical sample workflow(s)

Ownership and management of the system definition and architecture of all subsystem components of our laboratory developed tests.

Document all aspects of system design and development in accordance with design control requirements.

Develop and maintain requirement traceability through various subsystems and verification activities in collaboration with subsystem requirements owners

Contribute to data-driven decision making by designing experiments and collecting, analyzing, and presenting data results.

Lead and drive system risk management activities for system and subsystems throughout the development life-cycle

Mentor more junior systems engineers.

Establish and maintain alignment across multiple teams within the company with focus on execution, continuous improvement, and operational excellence.

Contributor to system design as well as capturing and managing the design

Systems and Process Engineering involving software and hardware implementations for life science products, in vitro diagnostics or medical devices under design control (21 CFR Part 820, ISO 13485) in a regulated environment.

Understand and generate deliverables related to design controls in support of a regulated industry.

Utilize nucleic acid based diagnostics technology knowledge and experience with next-generation sequencing and worked with other systems development needs in complex clinical diagnostic development environments.

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Immucor (Norcross, GA) Sep2019- Nov 2021

Senior Principal Systems Engineer (Technical Lead- Blood grouping instruments)

Design the overall architecture, verification, and test processes for medical devices consisting of complex integrated hardware and software systems.

Provide technical leadership on various engineering and scientific projects and/or sub-projects.

Software development life cycle for digital health..

Lead risk management team and define the hazards, failure and the required mitigation

Lead / participate in specific algorithm, mechanical, electrical or software designs.

Manage product requirements input and traceability tool, e.g. DOORS, Jama

Design and implementation of proof-of-concept simulations and/or prototypes.

Provide human factors and usability technical study

Interact with clinical and marketing teams on the development and translation of product, process, and stakeholder inputs to write requirements used by hardware and software.

Define and implement system verification and validation (V&V) protocols per company guidelines;

General Electric (GE) Healthcare and Amgen (U-system, Amgen, CA) Mar2016- Sept 2019

Principal System Engineer (Lead System Design Engineer).

Lead ultrasound imaging system engineering group (software, hardware, and clinical).

Gathers and analyzes input requirements and translates the user requirement into product specifications.

Ensure that there is alignment among the various products, technologies, roadmaps and corporate objectives.

Combination product: Risk Management, FMEA, FTA, Risk analysis Control (RAC).

Contributing in 510 K and premarket submission (PMA).

Worked with EU team for product compliance with EU-MDR regulation

Project management through engineering leadership, the initiation and completion of engineering projects and programs within budgetary guidelines while maintaining the standards of engineering excellence.

Perform the necessary tradeoffs (reliability, cost, schedule, manufacturability, etc.) of various design approaches and select an optimal approach.

Deep understanding of six sigma based design.

Ensure traceability between system requirements and verification/validation (V&V) testing.

Leads system validation, verification and image performance activities

Oversee and manage product development life cycle.

Fluent in FDA regulation and guidelines.

Baxter Healthcare (Hemodialysis) - Phillips Medesize Inc (Combination Products) Mar 2013 -Feb 2016

Senior Principal Systems Engineer - Lead System Design Engineer (LSD)

Deep understanding of drug/device combination product design and development.

Design automatic inhaler and pen injector for drug delivery, worked with infusion pumps.

Writing product requirement, specification test results, test plans and regulatory documents

(Risk management, FMEA, CAPA, quality plan, control design plan)

Writing system and subsystem requirement, specification, test plan, and test report

Oversee the whole system engineering progress in a highly matrix environment.

Participate in risk assessments and developing mitigation plans to ensure safe operation of the product

Plan and execute system level validation through pre-clinical evaluation.

Maintain high-quality documentation to meet quality management standards required for developing medical devices, and to enable successful exchange of information across the global program team

Integrating product sub-systems into fully integrated prototype systems and translating product requirements into actionable engineering requirements.

Product improvement, DFSS, Reliability, FMEA, FTA, and statistical analysis

Manage milestone, deliverable budget, timeline and product development progress

Solve design issues and implement creative solution

Douglass Scientific (Alexandria, MN) Mar 2011- Feb 2013

Senior Principal Systems Engineer / Manager

Design optical detection systems for PCR instrument

Company key expert for medical device development and FDA regulation.

Leads the creation of requirements, product specifications

Extensive Experience with automated IVD blood analyzers.

Reliability testing (accelerating reliability, accelerating models, reliability growth, etc.)

Managing overall project from timeline to the product launch

Provide active support to validation teams, review and approve data and documentation.

Deep understanding of polymers, plastics, and injection molding

Responsible for researching, and evaluating new advanced technologies

Siemens, Diagnostic Solutions Feb 2006- Mar 2011

Senior Staff Systems Engineer/Technical Manager (Flanders, NJ)

Experience with electromechanical devices, control, fluidic, liquid handling, pumps, motors and sensors.

Review design work to ensure architectural compliance, assess and evaluate design concepts and propose alternatives where appropriate.

Experience in coding using Labview and C software for breadboard control

Experience in writing technical reports in timely fashion, and present scientific findings at internal and external meetings

Design medical instrument architecture, generates risk management and develop risk mitigation strategies

Experience in product specifications, requirements (DOORS), test plans, test results, technical risks, DHF, FMEA, QFD, gage R&R, product reliability and (CAPA).

Lead subsystems verification/ validation (V&V) throughout the product development life cycle

Lead process validation such as operational qualification (OQ), installation qualification (IQ) and performance qualification (PQ).

Lead mass spectrometry front end sample preparation automation

Lead reliability team and product life testing

Developed allergy microarrays system based on optical detection and sandwich immunoassay.

Extensive experience in a wide range of medical devices technologies

Risk management 14971, code federal regulation 21CFR 820, and 510K submission

Interface with business partners, internal quality assurance unit and external regulatory authorities in order to fully comply with GLP and other pertinent regulations.

Working knowledge of experimental design and statistical software’s such as Minitab, DOE, DFSS ANOVA

Experience in bridging ideas across various disciplines of engineering, software, biology, and chemistry.

Panasonic Life Science Inc. (Irvine, CA) 2003-2006

Principal Scientist/Engineer

Product Development - Developed glucose monitor device for clinical diagnosis based on electrochemical detection (Marketed by Bayer Inc).

Developed multi-biosensor instrument for cholesterol, alanine and aspartate aminotransferase.

Developed cost effective high throughput patch clamp and biochip, ~ $100 M drug discovery systems and reduced the price per data point from 1.4$ to 0.3 $

Evaluated core technology requirements, implemented R&D strategy and formulated R&D team

Developed competitive HT patch clamp chip in the marketplace ~ 30M consumable market per year.

Secured 4 beta testers with possible commitments to purchase.

Managed project milestones, project timelines, and ensures that the resources assigned to projects are adequate to meet project objectives.

Established and maintained functionally integrated project schedules to enable accurate project and financial analysis and ensures inputs are provided to the management for accurate business planning processes.

Trained, managed, and supervised 19 scientists.

Aviva Biosciences Inc. (San Diego, CA) 2000-2003

Senior Staff Scientist

Developed multifaceted planar chip technology, and its corresponding surface treatment.

Reduced the biochip surface treatment procedure from 12 hours to 5 minutes, saving more than $100 million /year on chemicals, manufacture and mass production.

Overcame the major electrophysiological barrier by achieving a giga Ohms seal resistance, between the cell membrane and the biochip. The consumable chips become a renewable asset for Aviva biosciences Inc (Marketed by Molecular Device Inc, CA).

Rensselear Polytechnic Institute (Troy, NY) 1998-2000

Senior Research Scientist

Coordinated and evaluated Terahertz spectroscopy and imaging, and its medical application.

Provided expert analysis, testing and evaluation of terahertz biosensor (spectral and imaging).

Supervised staff scientists and PhD students to assist the integration of biosensor designs into the overall product and manufacturing scope.

Managed and communicated detailed project plans including timeline, critical path analysis, project budgeting, resource management, and risk identification.

Developed, for the first time, a new affinity biosensor device based on pulsed terahertz wave technology ~$70000.00 / instrument.

Natural Science and Engineering Research of Canada (NSERC) 1994-1998

Distinguished Research Scientist Fellow

Multiple Sclerosis society of Canada, National Institute of Health (NIH), and US environment protection agency (US-EPA)

Experience leading and participating in cross functional teams.

Experience in engineering surface “bio recognition systems”, used to design nanoscale medical devices.

Extensive experience in designing optical and electrical transducer tools to monitor the interactions, between solid material and biological substances.

Experience in protein and lipid characterization using a wide range of biophysical, analytical and imaging techniques.

Worked with DNA gaining understanding of sequencing.

Experience in thin film preparation techniques such as Langmuir-Blodgett, evaporation, and sputtering,

Broad command of spectroscopic techniques, such as Fourier transforms infrared spectroscopy, Raman spectroscopy, mass spectrometry (spectral and imaging), gas chromatography and nuclear magnetic resonance spectroscopy (NMR spectral and imaging).

EDUCATION:

PhD in Biophysics: Research Center of Energy and Bimolecular Information (University of Quebec at Three-Rivers, Canada).

Master’s Degree in Material Science (University of Constantine, CNRS Paris).

BS: Electronic Engineering: National Polytechnic Institute (Algiers)

Languages:

iv.Fluent in English, and French

Software programming:

v.MATLAB /Simulink, LabVIEW, Schematic Capture, PSpice

AWARDS:

vi.National Research Council Senior Research Associate-ship award (Oak Ridge Institute for Science and Education (ORISE- USA)

vii.Research scientist grants. National Institutes of Health (USA)

viii.Postdoctoral fellowship. Multiple Sclerosis Society of Canada.

ix.Canadian Society of Biochemistry. Molecular and Cellular Biology Post-doctoral travel award (Canada)

x.Postdoctoral fellowship. Natural Science and Engineering Research Council of Canada (NSERC).

xi.PhD Student fellowship

AFFILIATIONS:

xii.Member of Quebec (Canada) Professional Engineer

xiii.Spectroscopic society

xiv.Biophysical Society

PUBLICATIONS:

xv.5 Patents, 35 peer reviewed papers in high quality International Journals.

PATENTS:

xvi.Menikh Abdellah (US) ; Walker Geotrge (US); Wu Lei (US); Khachonesin Sithiphong (US); Xu JIA (US); huang Mingxian (US); Guia Ontonio (US); Yuan Julian (US)” High density ion transport biochip device measurement”. US patent # 200-***-****. International WO2006/033696 A3.

xvii.Menikh, S.P. Mickan & X.-C. Zhang, "Detection of biospecific interactions using amplified differential time domain spectrocopy signals," US 7368280 B2

xviii.S. Mickan, A. Menikh & X.-C. Zhang, " A terahertz time-domain biosensor " ... diagnostic apparatus," Australian Patent Office, No.PR2139,

xix.A.Menikh; J.Massaya: Cell electrophysiological sensor and method of manufacturing the same Patent # US 7608417B2.

xx.Menikh et al. Cell electrophysiological sensor and method of manufacturing the same part 2) Patent #US 200******** A1

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