Monica Patterson
Regulatory and Product Development Engineer
- Role
- Senior Sustaining Engineer at Cook Medical
- Location
- Dallas-Fort Worth, TX, US
- LinkedIn followers
- 500 followers
About Monica Patterson
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.
Experience
Senior Sustaining Engineer
Sep 2025 — Present · Bloomington, IN, US
Co-led 3 wire guide product lines to submission to the European Medicines Agency (EMA) for the EUMDR transition targeting ~$7.5 million protected annual sales• Supported post-submission and implementation activities for 7 wire guide product lines, targeting ~$31 million protected annual global sales
Education
Young Alumnae Leadership Program
Leadership
2020 — 2021
Colorado School of Mines
Bachelor's Degree, Chemical and Biochemical Engineering
2013 — 2017
Skills
- Chemical Engineering
- Risk Managment
- Comsol
- Lab Safety
- Cea
- Cad
- Loggerpro
- Co2 Epilog Fusion Laser
- Ha
- Applied Bioinformatics (Dna Sequencing)
- Organizational Leadership
- Wet Laboratory Experience
- Microsoft Office
- Process Engineering
- Technical Writing
- Instron
- Engineering
- Rmp
- Strategic Planning
- Communication
- Mathematica
- Solidworks
- Project Management
- Pmha
- Autocad
- Manufacturing
- Powerpoint
- Microsoft Excel
- Statistics
- Leadership
- Aspen
- Validation Engineering
- Teamwork
- Team Management
- Polymath
- Silanization
- Hazop
- Writing
- Microsoft Word
- Data Analysis
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