Daud Sharif

Andover, Massachusetts

C 857-***-****

adwjyw@r.postjobfree.com

www.linkedin.com/in/daudsharif

Summary

Software Engineering Management > 10 years

Electronics Engineering Management > 12 years

Agile Scrum Master >10 years

Hardware and Software Design > 12 years

Medical Devices > 10 years

Cyber Security / PKI >5 years

ISO 9001 > 10 years

FDA 21 CFR Part 11, 210, 211, 820, HIPPA, ISO 9001 >5 years

IEC 62304, IEC 82304, ISO 13485, EU Annex 11, EU MDR > 5 years

AS9100 D. AS9115 A, MDA-QS-001-MAP < 1 year

Led over a dozen engineering teams, including Hardware/Electronics Design, Software Development, QA, Build & Release, Documentation and Manufacturing Teams.

Domains include medical devices, war game simulations, e-clinical trials, HPLC, cryptography, online education, online game simulation, factory automation in startups and large corporations including Becton Dickinson, Waters, Accenture ($40 Billion Management Consulting firm), State of Maine and Siemens etc.

Designed over two dozen medical instruments for NIH, bio-pharmaceuticals firms, space instrumentation for NASA, assorted R&D, scientific and industrial instruments.

Specialties: New product development, iPhone and Android apps, web apps & enterprise level, hardware & software, embedded, medical devices, scientific instrumentation, proposal writing for NIH, DoD, NASA & SBIR, Waterfall and Agile methodologies and appropriate mix of the two.

Last, but not the least, Chat GPT and Google-fu.

Environments: Class 1, 2 & 3 Medical Devices, FDA 21CFR Part 820, 21CFR Part 11, IEC 62304, 82304, MDD, IVDR, SVN, Seapine TestTrack, SVN, DOORS, Jazz, Jira, embedded Nordic nRF51822, BLE, Microsoft Dynamics AX, Embedded HW, BLE 4.0, iPhone, Android, Amazon Web Services, SourceTree, ST Microelectronics DfuSe, Visual Studio 2013, Anaconda Python, Beyond Compare 4, iFunbox, TestFlight, Jira, Arena PLM, Agilent 34461A Multimeter, Keithley 2400 SourceMeter and MSO-X 3014A Oscilloscope, FDA 21 CFR Part 11, GaMP & HIPAA, Agile Scrum, Win 10, C#, .NET, SQL Server 2012, Microsoft Teams, SharePoint, Teams / Team Foundation Server (TFS), Borland Silk Test, Oracle Agile (PLM), I/O interface, RS-232, USB 3.x, TCP/IP, mechatronics, stepper motors, servo motors, proximity, barcode readers, laser sensors, microcontrollers, custom electro-mechanical grippers.

Experience

Consultant

Redwire Space

August 2022 – March 2023

• Controlled Unclassified Information (CUI) project; requires safeguarding or dissemination controls pursuant to and consistent with applicable law, regulations, and government-wide policies.

• Introduced Agile Scrum along with another Scrum Master, with Jira, on multiple projects, and ramped up the Dev, QE, Systems and Hardware teams by, decomposing user requirements to groomed product backlog, sprint planning, and scrum boards.

Associate Director, Quality Engineering

Quanterix

October 2021 – August 2022

• Built a new Quality Engineering team to meet the expanded needs of the business in disease biomarker detection and quantification.

• Introduced modified Agile Scrum with Jira and ramped up the QE team by identifying the product backlog, in accordance with corporate goals-based projects, sprint planning, and scrum boards.

• Provided leadership and oversight on several aspects, including IVDR gap analysis for next-generation system viz. HD-XR, ISO13485 gap analysis for key SOPs, Risk Management for several new assay kit development projects for big pharma, assay manufacturing support, ME, EE, SW Design Quality oversight for HD-X and SR-X instrument manufacturing by contract manufacturers, trend analysis of OOB failures, frequently replaced parts, etc., Change Control Board and Material Review Board meetings covering assays, mechanical, electrical and software changes, reduction of backlogs in Change Controls, Deviations, NCMRs and Supplier Management (ASL, SCARS etc.) Supported several internal and external audits.

• Oversaw the process mapping, development and launch of the complaint handling, MDR reporting, vigilance reporting process; reviewed complaints and addressed risks via the Risk Management process.

• Oversaw and contributed to gap analysis and upgrade of Standard Operating Procedures from ISO 9001 to ISO 13485 in preparation for IVDR compliance.

• Oversaw an initiative to identify a large number of suppliers into the Approved Suppliers List (ASL).

• Moved the team away from crisis management to a more sustainable workflow.

R&D Staff Software Quality Engineer

Becton Dickinson

October 2019 – October 2021

• Provided Quality Engineering oversight for the BD DC App, a Class I medical device, through several releases and facilitated Risk Management process for the App.

• Supported the process mapping, development and launch of the complaint handling, MDR reporting, vigilance reporting process; reviewed complaints on a weekly basis and addressed risks via the Risk Management process.

• Supported Scrum Master with Agile Scrum, with Jira, and ramped up the Dev and QE teams by identifying the product backlog, in accordance with project goals, sprint planning, and scrum boards.

• Supported gap analysis and upgrade of Standard Operating Procedures from Medical Devices Directive (MDD) to the Medical Device Regulation (MDR)

• Supported Zodiac project for the next generation Class II medical device insulin pump.

• Supported Swatch 1.5 and Mario.

• Conducted an internal Mario Mock Audit and prepped the team for big pharma external audit.

• Ran an initiative to identify a large number of suppliers into the Approved Suppliers List (ASL).

• Additional initiatives include Active membership in BDX QE Development Program; and providing guidance as a Mentor.

Senior Software Quality Engineer

Waters

February 2017 - October 2019 (2 years and 8 months)

• Participated In Agile Scrum with Jira and ramped up the QE teams by identifying the product backlog, in accordance with corporate goals-based projects, sprint planning, and scrum boards.

Provided Design Quality oversight and Risk Management process for the release of Empower and UNIFI software driver packs, viz Cyan, Denim, Emerald, Firebrick, Elm and Oak; new detectors viz. SQD2 and PDA and next generation system viz. Orion. Led an initiative to introduce Public Key Cryptography into Orion. Additionally, analyzed post release defect metrics and suggested ways to reduce technical debt and improve the new product development process.

R&D Scrum Master (Continued from Sunrise Labs)

Insulet Corporation

September 2015 – April 2016 (8 months)

Ramped up two new Class 3 medical device projects viz. an insulin pump and an artificial pancreas; built a team of Developers and introduced Agile Scrum Best Practices.

• Introduced Agile Scrum with Jira and ramped up the Dev & QE teams by identifying the product backlog, in accordance with corporate goals-based projects, sprint planning, and scrum boards.

R&D Consultant (See above)

Sunrise Labs, Inc.

March 2015 – August 2015 (6 months)

Wrote test cases for the Insulet insulin pump; then continued the same project at Insulet.

R&D Consultant

Quanttus

April 2014 – January 2015 (10 months)

Launched a QA Best Practices initiative within the firmware design team; conducted both functional testing and V&V; and successfully completed the project for submission to FDA 510(k) clearance.

Participated In Dev Agile Sprints.

R&D Consultant

Rapid Micro Biosystems

October 2013 – April 2014 (7 months)

Worked with Dev and QA and brought GEN 2 Robot project to completion whilst raising the quality bar and clarity of thinking via Venn diagrams, Pareto charts and clear delineation between Mechanical, Electrical & Software Engineering defects and issues. Changed the QA mandate from the risky SW-only to customer-focused HW & SW viz. full-instrument system verification.

• Introduced modified Agile Scrum with Jira and ramped up the QE team by identifying the product backlog, in accordance with corporate goals-based projects, sprint planning, and scrum boards.

Consultant to FT

Dassault Systemes SolidWorks

October 2011 – April 2013 (1 year 7 months)

Launched a QA Best Practices initiative and improved the standing of the Dev Team from CMMI Level 1 to Level 3; from nonexistent to defined, standard & consistent processes. Additionally, trained developers in QA Best Practices to conduct better QA in the absence of a non-existent QA team.

• Introduced Agile Scrum with Jira and ramped up the Dev team by identifying the product backlog, in accordance with corporate goals-based projects, sprint planning, and scrum boards.

Consultant

Department of Labor, State of Maine

December 2010 – October 2011 (11 months)

Revamped a stalled project by introducing Agile Scrum techniques whilst managing both Dev and QA Teams. Overcame the loss caused by departure of key engineers including other shortcomings, reinvigorated the Dev team and successfully delivered beta software to QA and stake holders over seven sprints.

Accenture Level B Executive

Accenture Federal Services LLC

March 2007 – March 2009 (2 years)

Built and managed several new teams for the US Air Force Modeling & Simulation Training Toolkit (AFMSTT) program whilst adhering to Agile Scrum principles at Accenture.

Manager, Clinical Operations Quality Management

PHT Corporation

April 2005 – August 2006 (1 year 5 months)

Oversaw the SQE team and an off-site SQE vendor in Croatia for clinical trials software. Optimized validation strategy and resource needs; hired, tweaked, trained, managed and led 5 QA engineers including a textbook case of a difficult team lead.

• Introduced modified Agile Scrum with Jira and ramped up the QE team by identifying the product backlog, in accordance with corporate goals-based projects, sprint planning, and scrum boards.

Lead Software Quality Engineer / Video Engineer (Consultant to FT)

DG Fast Channel

October 2002 – October 2003

Factory Works Software QA Manager

Brooks Automation

March 2001 – July 2002 (1 year 5 months)

Software QA Manager

Jenzabar.com

September 2000 – February 2001 (6 months)

Software QA Manager / IT Manager / Release Manager (Consultant to FT)

Simplayer Sports

February 2000 – September 2000 (8 months)

Consultant

CertCo

September 1998 – February 2000 (1 year 6 months)

Consultant

e-Parcel

March 1997 – February 1998 (1 year)

Consultant

The Foxboro Company / Invensys Systems

July 1996 – March 1997 (9 months)

Consultant

Keithley Metrabyte

March 1995 – July 1996 (1 year 5 months)

Engineering Manager, Electronic & Biomedical Instrumentation

Radiation Monitoring Devices

November 1988 – April 1992 (3 years 6 months)

Design Engineer

Columbus Instruments

November 1981 – August 1987 (5 years 10 months)

Publications

Solid state neutron dosimeter for space applications

The Smithsonian/NASA Astrophysics Data System

1990 SAO/NASA ADS Physics Abstract Service http://adsabs.harvard.edu/abs/1990rmdi.rept E

NASA Technical Reports Server (NTRS)

http://hdl.handle.net/2060/199********

A multileaf collimator for high energy linac

MLC Supplementary Information

1990 MLC Supplementary Information Vol.Jan. 30 Pages 1-2

CdTe detectors in nuclear radiation dosimetry

Nuclear Instruments and Methods in Physics Research

1992 Nucl. Instrum. Methods Phys. Res. A, Accel. Spectrom. Detect. Assoc. Equip. Vol.A322

Pages 623-627

Education

DeVry University

BSEET, Electronics Engineering, 1985

PROFESSIONAL COURSES

Certified ScrumMaster® (CSM) Certification ID: 488365 (Scrum Alliance) - 2016

Certified Scrum Product Owner® (Scrum Alliance) - 2016

ISO9001:2008 Training refresher class (Rapid Micro Biosystems) - 2013

Ethics - Insider Trading (Accenture) - 2009

Scrum Master Agile methodology (Accenture) - 2007

Auditor Certificate (PHT) - 2006

FDA 21 CFR Part 11 Training (PHT) - 2005

FDA 21 CFR Part 820 Training (PHT) - 2005

C++ (Keithley Metrabyte) - 1995

Neural Networks (Harvard University) - 1993

Fuzzy Logic (University of New Mexico) - 1992

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