Monica Patterson Email and Phone Number
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Experienced Engineer with a demonstrated history of working in the medical device industry. Skilled in Project Management, Risk Management, Medical Device Regulations, Technical Documentation, and Leadership. Secured approval of 6 medical device licenses to the PMDA and the MFDS. Possesses Dual Regulatory Affairs Certificate in Medical Devices and Pharmaceuticals from the Regulatory Affairs Professional Society. Strong background in Chemical and Biochemical Engineering from the Colorado School of Mines and currently a Regulatory Engineer Consultant at Kymanox.
Kymanox
View- Website:
- kymanox.com
- Employees:
- 100
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Regulatory EngineerKymanox Jun 2024 - PresentRegulatory writing of device information for combination productso 3.2.Ro Device Master File (MAF)o Type B, C, and D Meetingso Pre-IND, IND, and NDA submissions
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Engineer, Device Development And CommercializationKymanox Sep 2022 - Jun 2024Create and review documentation for combination products such as pre-filled syringes and auto-injectors:o Use Specifications, User Needs (UN), Design Input Requirement (DIR), and Design Verification and Validation (DV&V)o Risk Management Plans (RMP), Hazard Analysis (HA), Failure Modes and Effects Analysis (FMEA), and Risk Management Report (RMR)o Human Factor (HF) Plans and Summary Reportso 5.3.5.4 and 3.2.R Regulatory Draftingo Test Method and Process Development, Validation Protocols, and Validation Reports
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Sustaining Engineer Ii: Wire Guide (Guidewire) Subject Matter ExpertCook Medical Jan 2021 - Sep 2022Bloomington, Indiana Area• Created Design History File (DHF) and Risk Management Documentation to support Pilot Process for Continuous Flow Manufacturing for Star Product Line estimating annual global production savings of ~$1.4 million in 2022• Created and oversaw creation of DHF and Risk Management Documentation for the EUMDR transition targeting ~$59 million protected annual sales• Mentored and onboarded co-ops, contractors, and newer employees to secure a target of ~$29.2 million protected annual sales across all vascular access and lead management product lines• Oversees ~$71 million annual sales globally -
Engineering Project Leader: Apac License UpdatesCook Medical Aug 2018 - Jan 2021Bloomington, Indiana, United States• Led 7 product lines to submission to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA); Secured Market Authorization of 45 products in the Japanese market- Protected ~$300,000 in balloon catheter sales in 2019- Protected ~$700,000 in wire guide (guidewire) sales in 2020• Led 3 product lines to submission to the South Korean Ministry of Food and Drug Safety (MFDS); Secured Market Authorization of 35 products in the South Korean market- Protected ~$26,900 in balloon catheter sales in 2019- Secured KGMP Certification for Bloomington Manufacturing Facility protecting ~$45 million sales in 2020 across all product lines• Coordinated and led monthly test lab meetings to facilitate communication with testing personnel for all APAC regulatory compliance projects protecting ~$23.2 million annual sales
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EngineerCook Medical Jan 2018 - Aug 2018Bloomington, Indiana• Created DHF and Risk Management Documentation- Design Control Traceability Tables (DCTT / DRT), Use Specifications, User Needs (UN), Business Needs (BN), Design Input Requirements (DIR), Design Outputs (DO), and Design Verification (DV&V)- Risk Management Plans (RMP), Clinical Effects Analyses (CEA), Failure Modes and Effects Analyses (FMEA), Benefit Risk Analyses (BRA), and Risk Management Reports (RMR)
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Ambassador7 Cups Of Tea Feb 2016 - Dec 2019• Support individuals emotionally and listen to their thoughts and concerns• Answer questions, assist other listeners in chats, and suggest improvements for the site to better support members and guests.• Propose projects, manage listener and member teams, train listeners to enter higher management positions.• Assist the community with conflict resolution -
ResearchColorado School Of Mines Aug 2016 - May 2017• Designing and fabricating microfluidic devices with laser micromachinery• Characterizing flow field through these devices using uPIV• Integrating micropatterned proteins into microfluidic devices• Performing blood flow experiments in microfluidic devices• Use of a CO2 Epilog Fusion Laser to make various cuts in a 5 mm thick acrylic• Variation of power, speed, and frequency• Simulation of smooth microfluidic channels of 100 to 500 um thickness.• Creation of PDMS membranes using silanization• Use of blood flow perfusion assays to gauge effectiveness of cold bonded microfluidic devices -
Material And Energy Balances TutorColorado School Of Mines Jan 2016 - May 2016Golden, Co• Solidification of comprehension through review of weak areas• Reframing of understanding of course
Monica Patterson Skills
Monica Patterson Education Details
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Chemical And Biochemical Engineering
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Young Alumnae Leadership ProgramPost-Graduate
Frequently Asked Questions about Monica Patterson
What company does Monica Patterson work for?
Monica Patterson works for Kymanox
What is Monica Patterson's role at the current company?
Monica Patterson's current role is Engineer, Regulatory | Kymanox | Your Life Science Solutions Partner.
What is Monica Patterson's email address?
Monica Patterson's email address is mo****@****cal.com
What schools did Monica Patterson attend?
Monica Patterson attended Colorado School Of Mines, Young Alumnae Leadership Program.
What are some of Monica Patterson's interests?
Monica Patterson has interest in Civil Rights And Social Action, Education, Science And Technology, Human Rights, Animal Welfare, Health.
What skills is Monica Patterson known for?
Monica Patterson has skills like Microsoft Office, Powerpoint, Microsoft Word, Microsoft Excel, Chemical Engineering, Leadership, Team Management, Project Management, Solidworks, Teamwork, Process Engineering, Statistics.
Who are Monica Patterson's colleagues?
Monica Patterson's colleagues are Izi B., Shaun Devitt, Jessica Martin, Kyle Arend, Phd, Melissa Pischak, Stefanie Hurowitz, Andrew Moger.
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