Mackenzie Fehl Email & Phone Number

Palo Alto, CA, US

Irvine, CA, US

• Led the implementation and validation of novel automated heart valve sewing process into commercialization aligning with regulatory, R&D and manufacturing to ensure successful validation and approval
• Pursuing Black Belt certification by following DMAIC methodology to characterize critical to quality product features and optimize the performance of an automated sewing machine to produce acceptable product projected.
• Designed a measurement system and performed a gage R&R to assess the repeatability and reproducibility of the measurements to aid in the improvement of a critical design specification
• Identified major sources of variation for key product requirements, designed studies to evaluate the magnitude of variation, and generated solutions to reduce variation and improve product quality
• Created process sheets, SOPs, MES model, and certified first operators to novel process reducing cycle time from 13 minutes to 3.8 minutes per product and eliminating manual sewing
• Liaison between Singapore site to ensure alignment of validation strategy and execution requirements essential to meeting key deliverables needed to implement the automated process in unison

Irvine, CA, US

• Awarded Green Belt certification through increasing the efficiency of H202 cleaning process by developing a measurement system to track the usage of H202, analyzing data to find inefficiencies in the process, and.
• SME for the heart valve component products & manufacturing processes including line improvements, training/certification, updating manufacturing SOPs, equipment and tooling management and performing MRB dispositions
• Developed Excel Macro using VBA to automate the data collection process for pull test data from 2017 to 2020, pertinent in CAPA investigation and further implemented as a tool for quality reviews
• Managed all Value Stream Improvement Engineer (VSIE) activities including project selection, developing and calculating project metrics, coordinating with planning to analyze demand, and monthly leadership reporting
• Owned the creation and validation of new THV valve components consisting of developing manufacturing and inspection routines, writing a technical summary to prove non-inferiority to the current process capability.
• Investigated multiple NCRs for product specification failures, improper use of tooling, and processing errors by performing risk assessments, root cause analysis, and implementation of corrective actions

Irvine, CA, US

• Managed a Yellow Belt project and used 8-Step Problem Solving Method to minimize tool loss for the production floor
• Analyzed 16 sewing operation for a surgical mitral heart valve line to assess ergonomic risks and ensure safety for the operators
• Performed complaint testing on aortic heart valves to corroborate reports from the field and eliminate the issue with stent redesign
• Standardized production manufacturing aids for ease of use and cross training by reducing variation in the process

Juno Beach, FL, US

• Developed two new processes to prioritize and manage quality projects, capturing over 100 process steps
• Created 7 process control plans for a variety of processes including proper grease selection and confined space determination
• Developed quality dashboards in PowerBI to display quality project statuses, number of certifications, and NPV for VP reporting
• Documented the current state of safety communication and facilitated a safety communication Kaizen event to improve the process

Atlanta, Georgia, US

-Obtained over 30 samples from the Krofta Clarifier to perform efficiency testing aimed to optimize the chemical feed and ultimately reduce chemical costs by $60,000 per year -Automated a data collection process by learning how to export PI Process Book data to Excel for 20 different data points to cut out daily data entry -Learned how to perform.

Juno Beach, FL, US

-Collaborated with 18 sites to clean up and categorize a database of procedural documents which increased business continuity and allowed the sites to operate more efficiently -Arranged meetings with site managers to categorize and rename 3000 documents and identified over 800 of those documents as outdated, redundant, or trivial-Led a team of 18 members.

Industrial And Systems Engineering, Industrial Engineering

Education record