Experience

Formerly Meridian Medical Technologies | KDD

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Sr. Design Quality Engineer

  • May 2022 - Present

• Combination Products Engineer

  • May 2019 - Apr 2022

  • Served as product development/design control Subject Matter Expert for all site change controls. • Determined impact to DHF’s for 400+ manufacturing, test method, supplier, and design change projects.• Promoted a culture of design control for a facility that formerly only complied with pharmaceutical regulations.• Owned 2 CAPA’s that led to design changes of the EpiPen.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Change Management Specialist

  • Sep 2018 - May 2019

  • Ensured production, design control, and vendor changes were executed effectively through managing creation, evaluation, execution, and closure of changes based on ISO 13485 requirements. • Followed up on Impact Assessments (IAs) as needed to properly assess the change. • Reviewed change control plans and, as needed, provided guidance, coaching, and other leadership to help change owners and leaders develop optimized change control plans and documentation. • Facilitated the site Change Control Review Committee meeting by publishing agendas, inviting appropriate quorum, furthering meeting discussion, and publishing GMP records of minutes. Show less



Zimmer Biomet

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Design Quality Engineer

  • Jun 2017 - Sep 2018

  • Supported a global sterile/non-sterile packaging design remediation effort by reviewing and approving Design Verification protocols and reports to ensure compliance with internal SOP’s, ISO 14971, and ISO 13485. • Conducted Supplier Production Process Approval (SPPA/PPAP+) activities by performing FAL, inspecting supplier Control Plans & PFMEA, and approving Process Monitoring for CTQ’s. • Confirmed statistical confidence by identifying appropriate sample size in Test Method Validations (TMV) and Process Validations (OQ/PQ) activities. • Investigated complaints to determine root causes and initiate Issue Evaluations (IE) and CAPA’s as necessary. • Implemented various product nonconformance actions such as Quality Holds, Field Actions, Health Hazard Evaluations (HHE), and Global Recalls. • Performed FMEA to identify various hazards, harms, and risks to support New Product Introduction (NPI/NPD). • Reviewed Managed Changes to ensure proper justification for design change by considering impact to Risk Control, Design Control, Verification, Validation, and Design Control Traceability Matrix. Show less



Gastrode Edi Catheter (Startup)

• St. Louis

• Biomedical Engineer

  • Aug 2016 - May 2017

  • Collaborated with team members to design a respiratory sensor as a solution to ventilation support synchronization issues experienced by neonatal patients in the St. Louis community. • Considered User Needs and corresponding Design Inputs/Outputs. • Designed a novel electrode catheter to record diaphragm activity along the fundus of the stomach and proved device feasibility on a porcine stomach • Prototyped and 3-D printed a gastrostomy port button with a unique feature to allow passage of an Edi catheter • Created a business model by considering market research and FDA regulation Pre-Market Approval pathway Show less



Michelman

• United States
• Chemical Manufacturing
• 200 - 300 Employee

• Quality Assurance Intern

  • May 2015 - Aug 2015

  • Performed chemical testing on Critical to Quality physical properties of paper coatings, inks, composites, and other film barriers • Conducted quality assurance using Gaurdbanding techniques • Executed a study to confirm Reproducibility of measurements on new laboratory equipment • Investigated the Root Cause of non-conforming production batches and worked with operators to adjust cleaning processes • Performed chemical testing on Critical to Quality physical properties of paper coatings, inks, composites, and other film barriers • Conducted quality assurance using Gaurdbanding techniques • Executed a study to confirm Reproducibility of measurements on new laboratory equipment • Investigated the Root Cause of non-conforming production batches and worked with operators to adjust cleaning processes