Michael Mcgrath, Pmp work email
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Thirty years of project management experience in the development and commercialization of single use medical devices. Proven track of managing and delivering products to market according to plan and budget requirements. Experience in managing a variety of internally developed projects with cross-functional teams in the US, Europe, China and Brazil and external development partnerships (Contract Manufacturing) to successful launches.Specialties: Significant experience in developing single use disposables as well as capital equipment development. Developed products to serve several medical specialties specifically in Urology (urinary tract & kidney stone removal devices), Endoscopy (biliary stents, baskets, dilatation balloons and esoph & trach metal stents), Gynecology (implantable urinary stress incontinence devices) and Breast Health (Biopsy and Brachytherapy devices and imaging products). Experience in MS software with significant experience in MS Project, Excel, Word, PowerPoint and Visio; PMP certified and in good standing.
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Program Manager (Sustaining)Hologic, Inc. May 2013 - Jan 2023Marlborough, Ma• Lead cross-functional teams on key strategic projects• Develop and execute strategic project plans including schedules, budgets and resources• Define project resource requirements and negotiate team assignments with functional managers• Plan, coordinate and track project activities• Provide routine project status communications to project team and management• Take a lead role in scheduling and managing the sustainment of commercial products (i.e. UDI Implementation for Class I, II and III products, China and Brazil compliance, capital (UL compliance) and disposable products).• Manage internal/external processes to effectively drive program progress• Develop and monitor risk mitigation plans to ensure business and project objectives are met• Support outside contract/supply agreement, contract development and vendor management• Challenge functional groups to meet project goals and commitments• Provide leadership in support of strategic sourcing initiatives • Maintain compliance to Project Design History Files• Managed label compliance projects due to Brexit and MDD/MDR -
Lead Program ManagerHologic, Inc. Apr 2016 - Feb 2022Marlborough, Ma
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Sr. Management AdvisorOasis Systems, Inc. Sep 2012 - May 2013Lexington, Ma• Directed activities of project leads/resources, and coordinating with FM and PK leadership for budget and financial, and contracting activities.• Assisted with daily direction of PMO staff and task activities to meet Air Force users (i.e., AFMC) and organization work objectives, especially for the Services program and team.• Assisted as needed in preparing and reviewing program/project documentation, e.g. Determinations and Findings, Justifications and Approval Requests for Proposals (RFPs) and assist in source selections for services related efforts.
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Program ManagerBoston Scientific Corp Jan 2000 - Jul 2012- Managing a multi-disciplined, multi-site project team (>100 people with a budget >$23M) for the Gynecology Franchise to create a product [capital equipment and two disposables] for the treatment of excessive uterine bleeding (menorrhagia).- Managed several small multi-disciplined project teams for the Stone Franchise that lead to the successful commercialization of holmium-based laser products, stone fragmentation products and other related derivative products.- Managed a multi-disciplined, multi-site project team (budget > $2M) for the Pelvic Floor Franchise that led to the successful commercialization of a product generating $40M/yr for the treatment of Stress Urinary Incontinence (SUI).- Documented design and development activities in accordance with ISO 9001 certified corporate quality system -
Director Of OperationsTelemed Inc Jul 1999 - Dec 1999- Directed the daily activities for the manufacturing operations.- Managed sixteen people who provide the drive for a $2 million a year endoscopic accessory business.- Conducted the necessary engineering activities for the development and cost improvements of new/current endoscopic devices manufactured in the facility.- Responsible for the activities in the Quality department which include maintaining the adherence to the quality policy and procedures as well as creating and maintaining the Tech Files for products sold internationally.- Oversaw all aspects of regulatory affairs as it relates to FDA regulations and the European directives (EN46001/ISO9001/MDD).
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Mechanical EngineerCr Bard - Endoscopy Division Sep 1992 - Jul 1999- Managed multi-functional and multi-divisional project teams to produce therapeutic and diagnostic Class II disposable endoscopic devices vital to the growth of the business from concept through manufacturing.- Initiated physician interviews for product conceptualization involving focus groups and utilizing use and Design FMEAs, DOEs and Quality Function Deployment.- Coordinated internal and external (OEM’s) Technology Transfers from 510(k) Design Freeze into manufacturing.- Responsible for the coordination of activities for the creation and completion of Product Technical Files and understanding the regulations of the domestic and European directives (FDA/EN46001/ISO9001/MDD).
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Mechanical EngineerCr Bard - Critical Care Apr 1985 - Jul 1992Responsible for research and development of various elements of a new medical product based on fiberoptic blood gas sensing technology designed to monitor realtime blood gas levels during operations. Responsibilities included in-vitro and in-vivo product testing including animals, test method development, biocompatibility testing, labeling, component molding, executed verification testing, transfer into manufacturing and generally supported other R&D needs as required.Collaborated with outside suppliers to design and build custom components. Maintained product design history file with all relevant project documents.
Michael Mcgrath, Pmp Skills
Michael Mcgrath, Pmp Education Details
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Mechanical Engineering -
Chemistry, Physics
Frequently Asked Questions about Michael Mcgrath, Pmp
What is Michael Mcgrath, Pmp's role at the current company?
Michael Mcgrath, Pmp's current role is Happily retired!!.
What is Michael Mcgrath, Pmp's email address?
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What is Michael Mcgrath, Pmp's direct phone number?
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What schools did Michael Mcgrath, Pmp attend?
Michael Mcgrath, Pmp attended University Of Massachusetts At Lowell, Stonehill College.
What are some of Michael Mcgrath, Pmp's interests?
Michael Mcgrath, Pmp has interest in Children, Environment, Education, Science And Technology, Arts And Culture, Health.
What skills is Michael Mcgrath, Pmp known for?
Michael Mcgrath, Pmp has skills like Medical Devices, Cross Functional Team Leadership, Fda, V&v, Design Control, R&d, Iso 13485, Quality System, Product Development, Manufacturing, Commercialization, Biomedical Engineering.
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