Joshua Haley
Fort Collins,CO
Summary
Results-driven Master of Engineering in Biomedical Engineering with expertise in circuitry, materials, R programming, and manufacturing practices. Trained colleagues on 3D printers and SolidWorks while supporting product development from concept to prototype. Knowledgeable in medical device regulations, FDA reporting, aseptic gowning, and cGMP compliance.
Overview
5
5
years of professional experience
2
2
Certifications
Work History
Engineering Intern
Injectech
Fort Collins, CO
03.2024 - Current
- Conducted quality inspections of plastic molding parts adhering to ISO 20457 standards.
- Performed gauge R&R analysis to assess process repeatability and reproducibility.
- Developed solutions for inadequate gauge R&R values, improving measurement reliability.
- Trained employees in quality evaluation techniques, improving assessment accuracy.
- Facilitated design analysis meetings, aligning project development with quality goals.
- Utilized SolidWorks for designing parts addressing plastic molding challenges and engineering solutions.
- Operated Carbon X1 Bambu Labs 3D printer to produce SolidWorks designs efficiently.
- Maintained 3D printer and laser engraver to ensure optimal operational performance.
Medical Device Regulator Specialist - Contingent
Medtronic
Lafayette, CO
09.2022 - 06.2023
- Updated medical device reports, ensuring timely submission to FDA and compliance with regulatory standards.
- Assigned codes to ambiguous descriptions, enhancing clarity and accuracy for regulatory documentation.
- Collaborated with team to develop and implement efficient file closure methods, improving workflow and documentation management.
- Organized files and data using OneNote and Excel software.
- Utilized Microsoft Teams for communication, meetings, and scheduling.
- Enhanced understanding of medical terminology and techniques for effective communication.
Manufacturing Associate - Downstream
Cytovance Biologics
Oklahoma City, OK
08.2021 - 09.2022
- Executed cGMP protocols and techniques to ensure compliance with industry standards.
- Operated TFF systems, columns, and homogenizers to facilitate efficient processing.
- Performed aseptic techniques in BSC/LFH to maintain sterile environments.
- Adhered to standard operating procedures for equipment and process handling, reducing risks and promoting safety compliance.
- Maintained accurate daily logs of production data, enhancing operational transparency and accountability.
- Provided daily updates on manufacturing tasks, ensuring alignment with downstream workflows and improved communication.
- Completed inventory check-in of materials to uphold supply chain integrity.
Education
M.E. - Biomedical Engineering
Colorado State University
Fort Collins, CO12.2025
B.S. - Biomedical Engineering
University of Central Oklahoma
Edmond, OK05.2021
Skills
- SolidWorks CAD
- CAD drafting and modeling
- Circuit development
- MATLAB proficiency
- R programming
- Testing methodologies
- Gauge R&R analysis
- ANOVA R&R analysis
- Process optimization
- Prototype development skills
- Blueprint interpretation skills
- Manufacturing knowledge
- Microsoft Excel
- Team collaboration
- Problem-solving expertise
- Research methods
- Blueprint interpretation skills
- Drafting expertise
- Manufacturing knowledge
Certification
Six Sigma: White Belt - Linkedin
Timeline
Engineering Intern
Injectech
03.2024 - Current
Medical Device Regulator Specialist - Contingent
Medtronic
09.2022 - 06.2023
Manufacturing Associate - Downstream
Cytovance Biologics
08.2021 - 09.2022
M.E. - Biomedical Engineering
Colorado State University
B.S. - Biomedical Engineering
University of Central Oklahoma