Amanda Storm Email & Phone Number

West Chester, Pennsylvania, United States

Raynham, Ma, Us

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.

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.

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.

New Brunswick, Nj, Us

I worked here part-time as I finished my senior year at Drexel University.

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.

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

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.

Us

• Trained five new employees to operate the cash register• Assisted customers, ensured items were stocked, and maintained a pleasant environment

Us

· Trained ten new employees on customer service, food preparation, and register operation · Resolved customer complaints and contributed outside of work hours

· Filed patients' charts, records, and lab results for doctors · Prepared patient charts, managed mail/bills, and faxed prescriptions

Bachelor Of Science, Biomedical Engineering

Master Of Engineering Management, Engineering/Industrial Management