Ammon Marshall
Software Validation Engineer
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About
A self-motivated, skilled communicator with extensive experience in the software as a medical device field. Experienced QA engineer with strong documentation skills and a broad background in the Software Development Lifecycle and QA procedures. Proficient in collaborative teamwork and working on several priorities at once with tight deadlines and little supervision.
Proven experience in developing quality management projects according to software validation specifications across diverse environments. Ready to leverage expertise in software validation to drive quality and compliance.
Experience
Software Validation Engineer III - Smith and Nephew - Memphis, TN
(2023-01)
- Completed software validation for diverse software development groups, ensuring regulatory compliance across multiple countries by capturing requirements, conducting risk analysis, and guiding validation testing for proprietary and COTS software used in manufacturing processes, systems, and equipment.
- Managed software validation projects with cross-functional teams, ensuring accurate results and timely completion through coordinated planning, execution, and stakeholder communication.
- Supported CAPA initiatives by collaborating with cross-functional teams to identify and address quality issues, strengthening corrective and preventive action effectiveness.
- Led regular meetings with stakeholders and users, aligning requirements, resolving questions, and maintaining project momentum throughout software validation activities.
- Performed reviews of documentation to ensure accuracy and completeness, supporting compliant validation records and production readiness.
Software Validation Engineer - Myriad Genetics - US
(2021-01 - 2023-01)
- Applied AAMI training in Medical Device Software Validation to support compliant software development and validation activities.
- Built Software Validation Packets for diverse software development groups throughout the organization, organizing requirements, risk analysis, verification, and validation testing to demonstrate software safety for production use with patient samples.
- Led the project demonstrating that analysis and variant classification software met IEC 62304 standards, enabling expansion throughout Europe.
- Directed the Enterprise Quality Management project segment to completion months ahead of schedule, establishing a model for other EQM projects going forward.
Software Test Engineer - Myriad Genetics - US
(2010-01 - 2020-01)
- Developed and executed test plans meeting documentation requirements and regulations, exercising areas of highest defect density to increase confidence in newly developed software used to process patient samples.
- Gathered requirements, created test plans, and performed risk analysis for all projects on the Data Review software team, strengthening coverage and compliance.
- Collaborated with QA to create verification documents, ensuring the team delivered well-tested, compliant code.
- Operated as a Technical Project Manager for several months between managers, coordinating priorities and maintaining project continuity.
- Founded the Testing Community of Practice, developing and reviewing several SOPs to standardize testing practices.
- Resolved Production Help Tickets, restoring functionality and supporting continued software operations.
- Led weekly meetings with stakeholders, SMEs, and the software team to review risks and requirements, improving cross-functional alignment.
- Trained new employees in testing, data creation, database familiarity, applications and use, and documentation, accelerating team readiness.
- Collaborated with the software team to create Unicron, an automated end-to-end testing platform for the hereditary testing laboratory workflow.
- Contributed significantly to BOLT, transitioning Review to Paperless Review and improving proficiency by 200%.
- Contributed to uArray Application Creation, the introduction and implementation of 26 genes analyzed at Myriad, HCP Review application development, the beginning of the NGS pathway, and establishing the EU laboratory.
Data Analyst - Myriad Genetics - US
(2005-07 - 2009-01)
- Genetic data analysis with supervisor permissions for Sanger sequencing, large rearrangement analysis, and M13 controls while training new analysts and co-managing the M13 control process and WIP reports for the department.
Education
Bachelor of Science (BS) - Biotechnology, Minors in Chemistry and Music - Brigham Young University (2005-12)
