Hisham Salem, Pmp

Hisham Salem, Pmp Email and Phone Number

Program Management | Operations | Med Devices | Hardware | Systems | Imaging | Robotics @ SpectraWAVE, Inc.
Hisham Salem, Pmp's Location
Newtonville, Massachusetts, United States, United States
Hisham Salem, Pmp's Contact Details

Hisham Salem, Pmp personal email

n/a

Hisham Salem, Pmp phone numbers

About Hisham Salem, Pmp

Energetic and experienced professional with extensive engineering management expertise in the greater Boston high technology corridor. Deep domain knowledge in the medical devices industry across R&D, manufacturing, supply chain, and QA/RA. Strong execution skills, attention to detail, and adaptable leadership style have enabled me to meet and mitigate project challenges, and release products to market.• Project management style resulting in efficient operations, positive work environment, and staff retention.• Resolved issues with company CEO, COO, VP and GM to ensure business commitments are met.• Solely responsible for creation and setup of manufacturing operations for an $8M company.• Meticulous attention to detail resulting in successful milestone tracking and completion.• Expertise in regulatory, quality metrics & standards including ISO 9001, ISO 13485, ISO 14971, IEC 60601-1 & its collateral standards, IEC 60825-1, IEC 62304, IEC 62366, RoHS Directive, FDA 21 CFR 820,MDD 93/42/EEC, MDR, CMDR (Canada), ANVISA (Brazil), NMPA (China), MFDS (Korea), MHLW MO 169 (Japan). Specialties: Work Breakdown Structure, Design Compliance, R&D Engineering & Project Management, Risk Management File, Production Release, Operations Setup, ERP Development & Implementation and QMS Planning & Fulfillment. MS Project, MS Access and Atlassian Jira & Confluence.

Hisham Salem, Pmp's Current Company Details
SpectraWAVE, Inc.

Spectrawave, Inc.

View
Program Management | Operations | Med Devices | Hardware | Systems | Imaging | Robotics
Hisham Salem, Pmp Work Experience Details
  • Spectrawave, Inc.
    Director Of Program Management
    Spectrawave, Inc. Jul 2021 - Present
    Bedford, Ma, Us
    View
  • Globus Medical
    Director Of Program Management Office - Imaging, Navigation, Robotics
    Globus Medical Jun 2018 - Jul 2021
    Audubon, Pa, Us
    View
  • Globus Medical
    Director Of Product Development - Imaging
    Globus Medical Jan 2017 - Jun 2018
    Audubon, Pa, Us
    View
  • Globus Medical
    Group Manager, Program Management Office - Robotics
    Globus Medical Nov 2014 - Dec 2016
    Audubon, Pa, Us
    View
  • Ge Healthcare, Specialty Mr
    Hardware Engineering Manager
    Ge Healthcare, Specialty Mr Dec 2011 - Oct 2014
    Chicago, Us
    View
  • Ge Healthcare, Specialty Mr
    Engineering Project Manager / Program Manager
    Ge Healthcare, Specialty Mr May 2010 - Dec 2011
    Chicago, Us
    View
  • Ge Healthcare, Specialty Mr
    Site Qa Leader
    Ge Healthcare, Specialty Mr Nov 2009 - Apr 2010
    Chicago, Us
    ONI Medical Systems, Inc. was acquired by GE Healthcare.
    View
  • Oni Medical Systems, Inc.
    Director, Qa / Ra
    Oni Medical Systems, Inc. Feb 2009 - Oct 2009
    Us
    View
  • Oni Medical Systems, Inc.
    R&D Program Manager
    Oni Medical Systems, Inc. May 2007 - Jan 2009
    Us
    View
  • Oni Medical Systems, Inc.
    Director, Qa / Ra
    Oni Medical Systems, Inc. Mar 2006 - May 2007
    Us
    View
  • Oni Medical Systems, Inc.
    Engineering Project Manager
    Oni Medical Systems, Inc. Jul 2005 - Mar 2006
    Us
    View
  • Astir Technologies, Llc
    Operations Consultant
    Astir Technologies, Llc Nov 2004 - Jul 2005
    Concord, Massachusetts, Us
    Product Development, Beta Production, Operations Setup (Safety Testing, ERP, and Quality System Regulation setup).
    View
  • Oni Medical Systems, Inc.
    Manufacturing Manager
    Oni Medical Systems, Inc. Jan 2000 - Oct 2004
    Us
    View
  • Oni Medical Systems, Inc.
    Senior Electrical Engineer
    Oni Medical Systems, Inc. Aug 1998 - Dec 1999
    Us
    http://www.itnonline.com/company/oni-medical-systems-inc
    View
  • Aurora Imaging Technology, Inc.
    Hardware Engineering Manager
    Aurora Imaging Technology, Inc. Oct 1996 - Aug 1998
    (Formerly known as Caprius, Inc.)http://www.auroramri.com/
  • Advanced Nmr Systems, Inc.
    Senior Electrical Engineer
    Advanced Nmr Systems, Inc. May 1991 - Sep 1996
    http://www.nytimes.com/1997/08/20/business/ge-takes-a-20-equity-stake-in-advanced-nmr-systems.html
  • Gte Government Systems (Strategic Systems Division)
    Member Technical Staff - Electrical Design Test Engineering
    Gte Government Systems (Strategic Systems Division) Jun 1986 - Apr 1991
    Us
    (Now bought by General Dynamics C4 Systems)http://www.gdc4s.com/
    View

Hisham Salem, Pmp Skills

Medical Devices Quality System Quality Assurance Fda Iso 13485 Product Development Cross Functional Team Leadership Program Management Manufacturing Project Management R&d Design Control Engineering Testing Medical Imaging Leadership Process Improvement Validation Product Launch Process Engineering Engineering Management Lean Manufacturing Biomedical Engineering Dmaic Quality Management Electronics Product Management Capa Systems Engineering Document Management Continuous Improvement Iso 14971 Fmea V&v Design For Manufacturing Root Cause Analysis Iso Embedded Systems Microsoft Project Product Lifecycle Management Software Documentation Quality Control Iso 9000 Regulatory Affairs Labview Gmp Ce Marking Dicom Solidworks Microsoft Office

Hisham Salem, Pmp Education Details

  • Northeastern University
    Northeastern University
    Engineering Management - Operations Research
  • Boston University
    Boston University
    Electrical Engineering

Frequently Asked Questions about Hisham Salem, Pmp

What company does Hisham Salem, Pmp work for?

Hisham Salem, Pmp works for Spectrawave, Inc.

What is Hisham Salem, Pmp's role at the current company?

Hisham Salem, Pmp's current role is Program Management | Operations | Med Devices | Hardware | Systems | Imaging | Robotics.

What is Hisham Salem, Pmp's email address?

Hisham Salem, Pmp's email address is hm****@****eee.org

What is Hisham Salem, Pmp's direct phone number?

Hisham Salem, Pmp's direct phone number is +197865*****

What schools did Hisham Salem, Pmp attend?

Hisham Salem, Pmp attended Northeastern University, Boston University.

What skills is Hisham Salem, Pmp known for?

Hisham Salem, Pmp has skills like Medical Devices, Quality System, Quality Assurance, Fda, Iso 13485, Product Development, Cross Functional Team Leadership, Program Management, Manufacturing, Project Management, R&d, Design Control.

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