Experience

TELA Bio

• United States
• Medical Device
• 100 - 200 Employee

• Product Development Manager

  • Mar 2022 - Present

• Product Development Engineer

  • Mar 2020 - Mar 2022



Essential Medical, Inc.

• United States
• Medical Device
• 1 - 100 Employee

• Product Development Engineer

  • Oct 2015 - Mar 2020

  • Aided product development prototyping and R&D efforts to assess and improve functionality and usability • Created test plans, protocols, and reports for device verification and validation • Performed risk analysis and contributed to Failure Mode and Effect Analysis (FMEAs) • Contributed to regulatory submissions, including Design Dossier, FDA Investigational Device Exemption (IDE) Submission, IDE Supplements and Amendments • Identified, qualified, and initiated potential Pivotal IDE Study investigational sites • Assisted in the development and execution of a clinical training program for investigators and sales launch • Proctored investigational and commercial device cases, providing technical support and sharing best-practices • Trained national sales force and international distributors on product use, troubleshooting, and messaging • Aided development and execution of preclinical studies, including large order animal study



Avid Radiopharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Chemistry, Manufacturing, and Control (CMC) Intern

  • Mar 2013 - May 2015

  • Archived and maintained inventory of manufacturing batch records for Radiopharmaceutical PET drug Amyvid • Compiled manufacturing batch records into a concise Batch Log • Generated weekly reports for executives to oversee Contract Manufacturing Organizations (CMOs) • Reconciled differences between manufacturing records and CMOs • Observed production consisting of synthesis and quality control tests during technical site visit in order to monitor operation procedure and provide input



Thomas Jefferson University

• United States
• Higher Education
• 700 & Above Employee

• Clinical Research Assistant

  • Apr 2012 - Sep 2012

  • Created, organized, and maintained documents used in regulatory binders for subjects and personnel • Participated and was involved in the discussion of trial related medical decisions • Subject documentation for screening, enrollment, lab and imaging reports, IV infusions • Obtained and relayed health information between patients, nurses, and the research team • Preparation of reports for Institutional Review Board, FDA, and Data Safety Monitoring Board • Collaborated with investigative personnel on health studies including Cancer treatment and imaging diagnostic Alzheimer Disease trials