Lettice Liles
Newark,DE
Summary
Detail-oriented compliance engineering professional with extensive experience supporting medical device systems, EMC testing, and regulatory validation activities. Expertise in executing verification protocols, troubleshooting complex system-level issues, and ensuring adherence to IEC 60601 standards, FDA regulations, and ISO 13485 requirements. Proficient in cross-functional collaboration with engineering labs and manufacturing teams to facilitate product certification, mitigate compliance risks, and drive continuous quality improvements. Currently pursuing a Master of Science in Healthcare Systems Engineering at Johns Hopkins University, focusing on enhancing system-level compliance, safety, and performance within regulated healthcare environments.
Overview
12
12
years of professional experience
Work History
Senior Compliance Engineer Technician
Hologic
Newark, DE
12.2024 - Current
- Lead regulatory compliance and EMC testing activities for complex medical imaging systems, ensuring alignment with IEC 60601-1 and IEC 60601-1-2 standards for global market access
- Develop and manage verification documentation including VEPs, VERs, and DCNs, supporting CB Scheme certification and international regulatory submissions
- Coordinate with external test laboratories such as Intertek and UL to execute full EMC test campaigns, including radiated and conducted emissions and immunity testing
- Executed in-house pre-compliance EMC troubleshooting within controlled chamber environment to identify potential risks.
- Evaluate hardware changes (e.g., contactors, power assemblies, PCB updates) for EMC impact and determine appropriate level of re-evaluation (full vs. limited testing scope)
- Collaborate cross-functionally with R&D, Sustaining Engineering, and Field Service teams to support system readiness, test setup, and issue resolution during lab testing
- Support Clause 5 documentation reviews by aligning IFUs and technical documentation with EMC and safety standard requirements
- Track and manage system configurations, test conditions, and compliance risks to ensure accurate and traceable verification results
- Contribute to continuous improvement of compliance processes, documentation practices, and team communication workflows
Instrumentation Technician II
TA Instruments
New Castle, DE
09.2022 - 12.2024
- Installed, calibrated, and maintained scientific instrumentation, ensuring accurate system performance and reliability
- Troubleshot and repaired complex equipment by performing root cause analysis and component-level diagnostics
- Utilized analytical software tools to identify faults and support system optimization
- Performed functional testing and validation of instruments to verify performance against specifications
- Interpreted schematics and technical diagrams to assemble and configure instrumentation systems
- Collaborated with engineers and process technicians to resolve technical issues and improve equipment performance
- Documented test results, maintenance activities, and system performance data with high accuracy and traceability
- Applied safe work practices and ensured compliance with safety standards and procedures
- Communicated project status, technical findings, and priorities to cross-functional teams
Electro-Mechanical Assembler III
Omega Engineering
Swedesboro, NJ
11.2017 - 09.2022
- Assembled and tested complex electromechanical systems, including analog and digital circuit designs, in accordance with engineering specifications
- Performed surface mount and through-hole soldering, including rework and prototyping of printed circuit boards (PCBs)
- Interpreted schematics, wiring diagrams, and technical drawings to accurately build and configure products
- Conducted functional testing and troubleshooting using diagnostic tools (e.g., multimeters) to ensure product performance and reliability
- Evaluated finished assemblies for compliance with specifications, tolerances, and quality standards
- Collaborated with design engineers to support fixture development, laboratory testing, and prototype validation activities
- Assisted with calibration activities and supported lab operations across multiple product lines
- Served as Subject Matter Expert (SME) for 10+ product lines, providing training and cross-functional support to improve team capability and production efficiency
- Supported production demands by assisting across departments and resolving backlog challenges to meet delivery targets
Engineering Assembly Technician
Sunhillo Corporation
West Berlin, NJ
09.2014 - 05.2017
- Assembled and tested electronic devices supporting Air Traffic Control systems, ensuring accuracy and reliability of critical components
- Reviewed customer requirements and specifications to ensure correct order configuration and fulfillment
- Performed functional and visual inspections to identify defects and verify product quality prior to shipment
- Executed product and performance testing, documenting results to support quality assurance processes
- Maintained inventory levels, tracked materials, and supported production flow to meet delivery timelines
- Prepared shipping documentation and verified customer data to ensure accurate and compliant order processing
- Collaborated with engineering and operations teams to identify and resolve quality issues, improving overall production efficiency
- Supported order fulfillment activities including picking, packing, and coordinating incoming/outgoing shipments
- Maintained detailed production and shipment records to ensure traceability and process compliance
- Recognized for delivering high-quality work, strong problem-solving, and consistently meeting production deadlines
Education
Master of Science - Healthcare Systems Engineering
John Hopkins University
Baltimore, MD06-2028
Bachelor of Science - Business Administration (Information Technology)
Colorado Technical University
Colorado Springs, CO06-2026
Associate in Science (AS) - Engineering Technology
DeVry University
Chicago, IL04-2024
Certification - Information Technology Essentials
DeVry University
Chicago, IL02-2023
Skills
- EMC Testing & Pre-Compliance Evaluation (Radiated & Conducted Emissions/Immunity)
- IEC 60601-1 & IEC 60601-1-2 (Ed 41) Familiarity
- Verification & Validation Documentation (VEP, VER, DCN)
- CB Scheme Certification Support & Test Coordination
- Clause 5 Documentation Review & IFU Alignment
- Risk Assessment of Hardware Changes for Compliance Impact
- Collaboration with External Test Laboratories (eg Intertek, Ul)
- Surface Mount Technology (SMT) & PCB Assembly
- Soldering (SMT & Through-Hole)
- Blueprint & Schematic Interpretation (10 years)
- Electrical Assembly & Wiring of Control Systems
- Instrumentation & Equipment Repair
- Performance & Functional Testing
- Troubleshooting & Root Cause Analysis (10 years)
Compliance & Regulatory
Technical Skills
- Quality Assurance & Inspection
- Process Improvement (Lean / 5S)
- Production & Manufacturing Support
- Inventory Management & Material Control
- Inventory Management & Material Control
- Compliance with Technical Specifications
- Multimeters & Diagnostic Equipment
- Hand Tools & Assembly Equipment
- Technical Documentation & Reporting
- Strong attention to detail in regulated and precession environments
- Ability to interpret complex technical drawings and specifications
- Cross-functional collaboration with engineering, lab, and operations teams
Engineering & Quality
Tool & Methods
Core Strengths
Accomplishments
Recognized for strong performance, problem-solving, and meeting production and compliance deadlines
Additional Qualifications
- Licensed Practical Nurse (LPN) with clinical experience supporting patient care environments
- Strong understanding of regulated healthcare systems and safety requirements
- Experience supporting lab testing, system setup, and cross-functional engineering teams
Professional Focus
- Systems Engineering in Healthcare
- Medical Device Compliance & Safety
- Process Optimization in Regulated Environments
Timeline
Senior Compliance Engineer Technician
Hologic
12.2024 - Current
Instrumentation Technician II
TA Instruments
09.2022 - 12.2024
Electro-Mechanical Assembler III
Omega Engineering
11.2017 - 09.2022
Engineering Assembly Technician
Sunhillo Corporation
09.2014 - 05.2017
Bachelor of Science - Business Administration (Information Technology)
Colorado Technical University
Master of Science - Healthcare Systems Engineering
John Hopkins University
Associate in Science (AS) - Engineering Technology
DeVry University
Certification - Information Technology Essentials
DeVry University