Bio
I am a Systems Engineer with the US ITER Project and certified Engineer in Training (EIT) with 15+ years of experience in requirements management and testing, encompassing the fields of nuclear fusion, technical document authoring, proton therapy system development, validation engineering, pharma/medical device C&Q/V&V, and quality assurance.
My role is to collaborate with a project manager and the engineering team and take the lead to translate between the two to facilitate the achievement of a successful system. I have also served in the role of TPO for government procurements.
I have led test protocol authoring and execution, cross-disciplinary risk assessments, and medical device design and manufacturing projects involving a wide variety of systems and equipment while working in a FDA/ISO regulated industry. In addition, I have hands-on experience with aseptic-filling equipment and processes.
I am detail-oriented, yet adaptive, with strong communication, presentation, and computer skills. I hold a BSBME and MS in Biomedical engineering. I am a Certified Medical Device Compliance Professional (CMDCP) through CfPIE, as well as a certified Internal Auditor for ISO 13485, 19011, and 21CFR820. I am currently working towards my INCOSE CSEP certification.
Professional Experience
Systems Engineer
- ORNL, 2020 - Present
Systems Engineer II
- ProNova Solutions, 2015 - 2020
Validation Engineer
- Commissioning Agents Inc. (CAI), 2009 - 2014
Education
University of Tennessee, Knoxville 2002 - 2007
- BSBME, Biomedical Engineering with a minor in Materials Science Engineering
University of Tennessee, Knoxville 2007 - 2009
- Master of Science (M.S.), Biomedical Engineering w/ a concentration in Musculoskeletal Biomechanics
Professional Affiliations
Member of INCOSE - International Council on Systems Engineering