Alisha Hammond

About Alisha Hammond

New Product Development Principal Engineer, Project Leader, and Supplier Management Staff…

Experience

1. Distinguished Engineer, Quality and New Product Development

   Mentorneering

   Jul 2021 — Present

   Co-developed and executed elements of the design control program to fit the culture of the organization to make the process simpler and more effective. Emphasis on Risk Management.• Established “Mentorneering Days” after seminars for company employees to get even more personal mentoring for their specific projects. This idea expanded to companies purchasing “Mentoneering Days” as a resource for their engineers to get the guidance without slowing down other resources. It has also become a resource for short-term analysis or assignments that do not make sense as a regular project.• Process Validation completion on several projects.• Rewrote and completed risk management program upgrades to help bring CAPA systems into compliance in a six-month period.• Wrote change control programs that fit the culture and maturity of the institutions needing them.• Created realistic schedules using Project Management (PMP) tools to help companies better plan for where they could improve projects and when they could start recognizing revenue.• Completed extensive troubleshooting and process development for new product development on a high-volume automated manufacturing line that included over 60 in-line automated machines from five (5) independent lines that integrated into a single point to create finished goods.Wide variety of topics for on-site or remote seminars/training modules. Customization was included in many cases.• Project Management for Design• Design Controls• Risk Management for Medical Device• Quality Management Systems• Test Method Validation (including Measurement System Analysis)• Process Validation• Software Validation• Supplier Management• Statistics for Design Controls and Process Controls• Process Controls for Medical Device• Product Specification Development (also called Component Specification Development)• Component Qualifications• Corrective Action/Preventive Action/Nonconforming product and processes (CAPA)• Change ControlEtc.

Education

• Brigham Young University

  Bachelor’s Degree

• Brigham Young University

  Master’s Degree

Skills

• Iso 13485
• Quality System
• Fda
• Product Launch
• U.s. Food and Drug Administration (Fda)
• Design of Experiments
• Manufacturing
• Microsoft Office
• Team Leadership
• Root Cause Analysis
• Project Planning
• Design Control
• Program Management
• Validation
• Medical Devices
• Capa
• Project Management
• Continuous Improvement
• Failure Mode and Effects Analysis (Fmea)
• Product Development
• Cross-Functional Team Leadership
• Lean Manufacturing
• Research and Development (R&D)