Amanda Storm Email and Phone Number
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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.
Depuy Synthes
View- Website:
- thenext.jnjmedtech.com
- Employees:
- 36068
-
Depuy SynthesWest Chester, Pennsylvania, United States -
Launch Management Lead - Supply Chain Product Management, TecaDepuy Synthes Aug 2021 - PresentRaynham, Ma, Us -
Senior Project Manager - New Product Introduction Supply Chain, TraumaDepuy Synthes Nov 2017 - Aug 2021Raynham, 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. -
Product Engineer Ii / Project ManagerJohnson & Johnson Mar 2016 - Nov 2017New 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. -
Associate Product Engineer / Project ManagerJohnson & Johnson Aug 2014 - Mar 2016New 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. -
Product Engineer (Temp)Johnson & Johnson Sep 2013 - Aug 2014New Brunswick, Nj, UsI worked here part-time as I finished my senior year at Drexel University. -
Product Engineer Co-OpJohnson & Johnson Apr 2013 - Sep 2013New 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. -
Product Engineer Co-OpAnimas, A Johnson & Johnson Company Apr 2012 - Sep 2012New 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 -
Specialty Instruments Engineer Co-OpStryker Orthopaedics Mar 2011 - Sep 2011Kalamazoo, 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. -
CashierExxonmobil Aug 2008 - Sep 2010Us• Trained five new employees to operate the cash register• Assisted customers, ensured items were stocked, and maintained a pleasant environment -
Sandwich ArtistSubway Sep 2007 - Sep 2010Us· Trained ten new employees on customer service, food preparation, and register operation · Resolved customer complaints and contributed outside of work hours -
Office AssistantKaleidoscope 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
Amanda Storm Education Details
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Drexel UniversityBiomedical Engineering -
Penn State World CampusEngineering/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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