Amanda Storm

Amanda Storm Email and Phone Number

Launch Management Lead - Supply Chain PM at DePuy Synthes @ DePuy Synthes
West Chester, Pennsylvania, United States
Amanda Storm's Location
West Chester, Pennsylvania, United States, United States
Amanda Storm's Contact Details
About Amanda Storm

With over ten years of experience in the medical device industry, I am currently a Launch Management Lead at DePuy Synthes (Johnson & Johnson). I have a Master's degree in Engineering Management from Penn State and a Bachelor's in Biomedical Engineering from Drexel.Throughout my career, I have led multiple cross-functional teams and managed the end-to-end supply chain for new product introductions and lifecycle management. I have experience with project and budget planning and management, risk analysis, supplier management, validations and qualifications, cost and capacity analysis, FDA submission support, design and drawing reviews, and mentorship. My passion is to provide doctors, patients, and families with the best products and services that can improve their lives.

Amanda Storm's Current Company Details
DePuy Synthes

Depuy Synthes

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Launch Management Lead - Supply Chain PM at DePuy Synthes
West Chester, Pennsylvania, United States
Employees:
36068
Amanda Storm Work Experience Details
  • Depuy Synthes
    Depuy Synthes
    West Chester, Pennsylvania, United States
  • Depuy Synthes
    Launch Management Lead - Supply Chain Product Management, Teca
    Depuy Synthes Aug 2021 - Present
    Raynham, Ma, Us
  • Depuy Synthes
    Senior Project Manager - New Product Introduction Supply Chain, Trauma
    Depuy Synthes Nov 2017 - Aug 2021
    Raynham, Ma, Us
    • Managed a program for improvements to the current portfolio of 60 BioMedical Enterprises (BME) nitinol implant and drill kit SKUs (including a total of 300 unique components) as the directly responsible individual for end-to-end supply chain management.• Supported the integration of the BME business into DePuy Synthes (via quality system and legal manufacturer changes) and closure of the BME facility by establishing a new supply chain for BME products.• Led the supply chain efforts for a new product introduction (NPI) for a BME nitinol staple for treatment of hammertoes.• Validated a new plastic injection molding supplier for BME components including Installation, Operational, and Performance Qualification (IOPQ) protocols and reports, process capability, and drawing and inspection plan reviews, while reducing the number of molds and SKUs and improving component quality.• Performed process capability and investigated failures on hammertoe implants using Design for Manufacture and Assembly (DfMA) principles.• Directed a new assembly, packaging, and labeling supplier through ultrasonic cleaning, packaging sealing, transit, and assembly validations.• Collaborated closely with Plan and Marketing to ensure supply chain continuity on BME products, evaluate trade-off decisions, and ensure sufficient capacity at suppliers.• Assessed design features/intent, manufacture processing and assembly, tolerancing, and material properties by coordinating experiments with R&D and Quality to investigate slider force failures on implant insertion sticks assemblies.• Managed a total of $5MM in project capital and expense and $2MM in inventory.• Supervised and guided three contractor direct reports and one indirect report in supply chain project management deliverables and supplier management.
  • Johnson & Johnson
    Product Engineer Ii / Project Manager
    Johnson & Johnson Mar 2016 - Nov 2017
    New Brunswick, Nj, Us
    • Obtained two successful FDA supplement approvals for changes to a Class 3 medical device.• Led multiple cross functional teams through lifecycle projects on current Vibe and OneTouch® Ping™ products.• Ensured supply chain continuity by delivering on End-Of-Life (EOL) and supplier changes.• Undertook product stewardship responsibilities to ensure RoHS/REACH compliance and detail materials currently used in all pumps and accessories.• Established and later improved a process and template to define project requirements, deliverables, and impact cross-functionally and across all of Diabetes Care• Composed Installation, Operational, and Performance Qualification (IOPQ) protocols and reports.• Mentored and instructed multiple coworkers in project leadership and end-to-end management.
  • Johnson & Johnson
    Associate Product Engineer / Project Manager
    Johnson & Johnson Aug 2014 - Mar 2016
    New Brunswick, Nj, Us
    • Obtained two successful FDA supplement approvals for changes to a Class 3 medical device.• Led multiple cross functional teams through lifecycle projects on current Vibe and OneTouch® Ping™ products.• Ensured supply chain continuity by delivering on End-Of-Life (EOL) and supplier changes.• Composed Installation, Operational, and Performance Qualification (IOPQ) protocols and reports.• Trained a manufacturing floor of 50+ operators through a performance qualification for the Pediatric launch of Vibe. • Mentored and instructed multiple coworkers in project leadership and end-to-end management.
  • Johnson & Johnson
    Product Engineer (Temp)
    Johnson & Johnson Sep 2013 - Aug 2014
    New Brunswick, Nj, Us
    I worked here part-time as I finished my senior year at Drexel University.
  • Johnson & Johnson
    Product Engineer Co-Op
    Johnson & Johnson Apr 2013 - Sep 2013
    New Brunswick, Nj, Us
    • Supported warranty Cost Improvement Projects (CIP) resulting in annual savings of $1+ MM/year.• Managed and developed testing for alternate OLED display, yielding a projected CIP of $600 M/year.• Generated and executed test protocols and verification/validations for design improvements and Corrective Actions/Preventative Actions (CAPAs).• Executed a Six Sigma process to evaluate and present statistical data via Minitab.• Utilized SolidWorks to modify mechanical drawings.• Tested the OneTouch® Ping®, Vibe®, and 2020 insulin pumps and their components for strength, durability, and functionality in accordance with current standards.
  • Animas, A Johnson & Johnson Company
    Product Engineer Co-Op
    Animas, A Johnson & Johnson Company Apr 2012 - Sep 2012
    New Brunswick, Nj, Us
    - Developed and executed test protocols and verification/validations for design improvements and Corrective Actions/Preventative Actions (CAPAs)- Executed a Six Sigma process to evaluate and present statistical data via Minitab- Tested the insulin pump and its electromechanical components for strength, durability, and functionality in accordance to current standards- Recommended design solutions to current design problems- Collaborated with Operations, Quality, and R&D on key projects- Presented projects and learning experience to supervisors
  • Stryker Orthopaedics
    Specialty Instruments Engineer Co-Op
    Stryker Orthopaedics Mar 2011 - Sep 2011
    Kalamazoo, Mi, Us
    • Designed and modified custom alterations to standard instrumentation using ProEngineer through reverse engineering and Engineering Change Notifications (ECNs).• Utilized tolerance stack-up analyses and Geometric Dimensioning /Tolerancing (GDT) to define geometric requirements.• Ensured surgeon satisfaction was achieved for custom designed forceps by revising and altering to customer specifications.• Executed Good Manufacturing and Documentation Practices (GMP, GDP) in accordance with ISO 13485.• Tested instruments for failure mechanisms and design issues.• Collaborated with Suppliers, Manufacturing, Inspection, Quality, and other engineers on projects.
  • Exxonmobil
    Cashier
    Exxonmobil Aug 2008 - Sep 2010
    Us
    • Trained five new employees to operate the cash register• Assisted customers, ensured items were stocked, and maintained a pleasant environment
  • Subway
    Sandwich Artist
    Subway Sep 2007 - Sep 2010
    Us
    · Trained ten new employees on customer service, food preparation, and register operation · Resolved customer complaints and contributed outside of work hours
  • Kaleidoscope Medical Associates
    Office Assistant
    Kaleidoscope Medical Associates Jun 2006 - Aug 2006
    · Filed patients' charts, records, and lab results for doctors · Prepared patient charts, managed mail/bills, and faxed prescriptions

Amanda Storm Skills

Medical Devices Project Management Cross Functional Team Leadership Process Improvement Iso 13485 Matlab Minitab Manufacturing Six Sigma Microsoft Excel Microsoft Office Testing Validation Powerpoint Solidworks Pro Engineer Microsoft Word Labview Soldering Lean Manufacturing Engineering Biomedical Engineering Quality System Product Design Design Of Experiments Quality Assurance R&d Data Analysis Visio Access Maple German Team Leadership Troubleshooting Autocad Statistics Gel Electrophoresis Technical Writing Ptc Creo Capa Dmaic Fmea Biomechanics Biomaterials

Amanda Storm Education Details

  • Drexel University
    Drexel University
    Biomedical Engineering
  • Penn State World Campus
    Penn State World Campus
    Engineering/Industrial Management

Frequently Asked Questions about Amanda Storm

What company does Amanda Storm work for?

Amanda Storm works for Depuy Synthes

What is Amanda Storm's role at the current company?

Amanda Storm's current role is Launch Management Lead - Supply Chain PM at DePuy Synthes.

What is Amanda Storm's email address?

Amanda Storm's email address is as****@****ail.com

What is Amanda Storm's direct phone number?

Amanda Storm's direct phone number is +161042*****

What schools did Amanda Storm attend?

Amanda Storm attended Drexel University, Penn State World Campus.

What are some of Amanda Storm's interests?

Amanda Storm has interest in Testing, Baking, Soldering, Painting, Product Design, Drawing, Animal Welfare.

What skills is Amanda Storm known for?

Amanda Storm has skills like Medical Devices, Project Management, Cross Functional Team Leadership, Process Improvement, Iso 13485, Matlab, Minitab, Manufacturing, Six Sigma, Microsoft Excel, Microsoft Office, Testing.

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