James Finch
Indianapolis,IN
Summary
Dedicated Engineer with a passion for medical innovation and safety.
www.linkedin.com/in/jrobertfinch
Overview
8
8
years of professional experience
Work History
Technical Project Manager
Adjutant Solutions Group
03.2024 - 12.2024
- Completed full-time project management work associated with Eli Lilly's DDCS (Delivery. Device, and Connected Solutions). Associated projects covered all five phases of the medical device lifecycle from initial designs to post-market followup.
- Partnered with project team members to identify and quickly address problems.
- Communicated project plans and progress to key stakeholders and project contributors.
- Organization, verification, and indexing of all documents associated with Design History Files with Eli Lilly products.
- Covered project management work associated with implementation of new electronic quality management system (eQMS) for ASG.
Test Method Validation Engineer
Cook Medical
04.2022 - 03.2024
- Test Method Validation Engineer consulting on a large scale EUMDR remediation project at Cook Medical.
- Investigating, organizing, and executing test method validations.
- Development and validation of new and existing test methods.
- Drafting of test method instructions, controlled inspections, controlled trainings for Quality Control inspection documents.
- Contracted through Akkodis
Data Analyst
Freelance
01.2017 - 03.2024
- Compiled, sorted, and verified digital data against source documents
- Interpret client data into easily digestable tables, figures, and graphs for group analysis.
- Observe and report trends in data and reviewed database entries to verify regulatory compliance.
COVID-19 Test Coordinator
Southwest Texas Regional Advisory Council (STRAC)
05.2020 - 08.2021
- Coordinated testing for Texas Department of Criminal Justice (TDCJ), Texas Juvenile Justice Department (TJJD), as well as community facility testing and nursing homes.
- Intake patient data and coordinated scheduling at multiple locations across Southwest Texas.
- HIPPA Compliant distribution of test result information
- Staffed by Robert Half
Education
Master of Science - Biomedical Engineering
University of Texas Health San Antonio : University of Texas San Antonio
San Antonio, TX05-2022
Bachelor of Science - Biomedical Engineering
University of Texas San Antonio
San Antonio, TX05-2020
Skills
- Technical Project Management
- EUMDR Remediation
- Test Method Validation
- Test Method Development
- ISO/ASTM Consensus Standards
- Hazard / Risk Analysis
- Gage R&R
- cGMP Regulations
- SolidWorks
- Microsoft Office
- Good Record Keeping Practices
- Prototype Development
- Mechanical Testing
- Root Cause Analysis
- jBASE
- Agile Product Lifecycle Management
- MDF Complaint Evaluation
- IQ/OQ/PQ
- Engineering Study Design
Timeline
Technical Project Manager
Adjutant Solutions Group
03.2024 - 12.2024
Test Method Validation Engineer
Cook Medical
04.2022 - 03.2024
COVID-19 Test Coordinator
Southwest Texas Regional Advisory Council (STRAC)
05.2020 - 08.2021
Data Analyst
Freelance
01.2017 - 03.2024
Master of Science - Biomedical Engineering
University of Texas Health San Antonio : University of Texas San Antonio
Bachelor of Science - Biomedical Engineering
University of Texas San Antonio
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