Kyle Wilkins
Aliso Viejo
Summary
Results-driven Engineering professional with over 8 years of experience in mixed-volume manufacturing and product development, complemented by hands-on healthcare expertise. Proficient in process optimization, quality control, and leading cross-functional teams to foster innovation through data-driven strategies. A proven leader in talent development and continuous improvement, dedicated to leveraging technical and clinical insights to enhance patient outcomes. Notable achievements include significant cost reduction and productivity enhancement through the application of lean manufacturing principles and statistical analysis.
Overview
11
11
years of professional experience
Work History
Emergency Medical Technician & Team Lead/Trainer
Miramar Health
Laguna Hills
02.2024 - Current
- Provide critical monitoring and medical intervention for up to 10 high-risk, acute patients with complex conditions, including mental health, cardiac, and multi-system deficiencies
- Implemented structured training programs for new staff ensuring compliance with safety and quality assurance standards.
- Audit medication documentation for accuracy, identifying process gaps and leading improvement initiatives to ensure compliance with safety and regulatory protocols
Project Engineer
Kerry Ingredients
Rome
06.2021 - 06.2022
- Led process validation activities (IQ/OQ/PQ) to ensure manufacturing operations exceeded strict design and regulatory requirements, while maintaining alignment with GMP principles and site safety standards.
- Conducted root cause analysis and Failure Mode and Effects Analysis to identify and resolve manufacturing inefficiencies, reduce operational downtime, and increase overall product throughput.
- Partnered with cross-functional teams (QA, R&D, and Operations) to optimize manufacturing workflows and validate new equipment installations, utilizing Lean Six Sigma methodologies.
Manufacturing Engineer
Whitepath Fabtech
Ellijay
09.2019 - 02.2021
- Qualified NPD design proposals to ensure manufacturability through component and product drawing validation, tolerance stackup, process capability analysis and benchmark testing
- Spearheaded Kanban material replenishment implementation site-wide, reducing internal lead times by 15% to improve operational efficiency and reduce time-to-market for custom product solutions
- Led deployment of continuous improvement initiatives for component sourcing and materials management which resulted in cost savings and increased production efficiency
Mechanical Engineer II
Emerson Automation Solutions
Black Mountain
05.2014 - 05.2018
- Executed $1M value engineering cost-reduction initiative to strengthen market positioning, including design for manufacturability, Finite Element Analysis review, vendor capability assessments, and prototype testing
- Created Critical-to-Quality (CTQ) inspection criteria for new-to-market and existing product solutions, ensuring product safety and reliability through risk assessments and product validation testing
- Led cross-functional teams for new product implementation and served as the lead trainer for certification activities to ensure compliance with domestic and international industry safety standards
- Implemented manufacturing process compliance procedures for 7 mixed volume and design-to-order product lines, including first pass yield monitoring, defective component disposition, and bill of material accuracy
Education
Bachelor of Science - Mechanical Engineering
Georgia Institute of Technology
Atlanta, GA01.2013
Emergency Medical Technician Certification -
ProTech Life Safety Services
Orange, CA01.2023
Skills
- Root Cause Investigation
- Proficient in DFMEA Processes
- Process Control Analysis
- Risk Mitigation Strategies
- ISO 9001 Compliance
- ISO 13485 Compliance
- Regulatory Affairs Knowledge
- Expertise in GMP Standards
- Product Testing Expertise
- Documentation Control
- Supplier Compliance Audits
- AutoCAD Proficiency
- ERP Systems (SAP, Oracle, INFOR)
- Experienced with Microsoft Office Applications
- Workforce Training
- CPR Certified Professional
Technical Skills
Root Cause Analysis, DFMEA, Statistical Process Control, Risk Management, ISO 9001, ISO 13485, FDA, Good Manufacturing Practices (GMP), Product Validation & Testing, Documentation Control, Supplier Quality Audits, AutoCAD, ERP Systems (SAP, Oracle, INFOR), Microsoft Office Suite
Timeline
Emergency Medical Technician & Team Lead/Trainer
Miramar Health
02.2024 - Current
Project Engineer
Kerry Ingredients
06.2021 - 06.2022
Manufacturing Engineer
Whitepath Fabtech
09.2019 - 02.2021
Mechanical Engineer II
Emerson Automation Solutions
05.2014 - 05.2018
Bachelor of Science - Mechanical Engineering
Georgia Institute of Technology
Emergency Medical Technician Certification -
ProTech Life Safety Services
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