10+ years in FDA-regulated medical device manufacturing. Capital programs, automation, team development, and operational excellence — led manufacturing engineering teams across multiple sites.
Capital equipment programs
Automation integration
Global line transfers
Validation & compliance
URS → supplier selection → FAT → SAT → commissioning → IQ/OQ/PQ → production release
The line running down this page is a working simulation — release a work order and watch it run.
Lead the manufacturing engineering group, evaluating technical options and presenting recommendations to the senior leadership team to guide capital and operational decisions.
Own a $22M automation program across its full lifecycle: authoring user requirement specifications, sourcing and selecting automation suppliers to deliver within an allocated capital budget, escalating variances to senior leadership with cost justification, and partnering with Purchasing on contract execution.
Served as primary technical interface to the automation integrator from design through delivery, driving international factory acceptance testing (FAT), on-site site acceptance testing (SAT), installation, commissioning, and IQ/OQ/PQ validation to production release.
Sustain and improve automated equipment performance after production release, resolving equipment and process issues, tuning cycle time and throughput, and feeding lessons learned back into specifications for subsequent automation projects.
Drive Lean adoption and continuous improvement on the floor, standardizing workflows across two sites and building accountability into daily operations.
Executed cost reduction strategy delivering $1.7M in recurring annual savings through scrap and rework elimination.
Industrialized NES, a new Diasorin platform, from pre-commercial state through process qualification to first commercial release — building manufacturing processes, SOP frameworks, and inspection controls from the ground up.
Directed transfer and industrialization of the PLEX product line from Luminex following acquisition, taking a pre-commercial acquired platform through site standup and validation to commercial release.
Built an Incoming Quality Control function from the ground up, specifying and implementing CMM, Keyence, and Nikon measurement systems, establishing inspection standards, and training staff to documented procedures.
Govern supplier selection and technical engagement, evaluating capability, risk, and total cost to drive sourcing decisions and contract execution in a regulated medical device environment.
Medtronic
Manufacturing Engineer, Global Transfer & Operations · 2-Year Contract
Irvine, CA
Jan 2021 – Jan 2023
Led cross-functional project teams through global transfer of React 68/71 and Pipeline catheter platforms to offshore facilities, expanding manufacturing capacity 200%.
Owned transfer program execution end to end, governing scope, timeline, and cost across international sites in a regulated environment.
Built and institutionalized the core program framework of charters, risk matrices, and integrated timelines, later reused across subsequent transfer efforts.
Resolved a critical catheter mandrel yield constraint using structured A3 root cause analysis, restoring production stability.
Orchestrated pilot builds and post-transfer validation across global sites using Agile and Waterfall frameworks to confirm production readiness.
Directed facility readiness through 5S and spatial redesign, integrating new lines while maintaining cleanroom compliance.
Partnered with Sales, Quality, and Product Management to align transfer strategy with commercialization and demand plans.
The HydraFacial Company
Project Manager, Operations & Site Relocation
Long Beach, CA
Jan 2020 – Jul 2020
Led the cross-functional team relocating manufacturing operations from Signal Hill to a new Long Beach facility, directing execution and vendor coordination with no loss of production continuity.
Governed SAP HANA implementation across manufacturing, improving inventory tracking accuracy by 20%.
Directed integrated schedules for complex product line transfers, aligning Engineering, Operations, and Quality to on-time launch.
Navigated municipal regulatory requirements with city inspectors, clearing compliance constraints without schedule slip.
The HydraFacial Company
Senior Manufacturing Engineer
Long Beach, CA
Jun 2019 – Dec 2019
Launched a standardized manufacturing documentation framework covering travelers, rework flows, and SAP routings to support production scalability.
Implemented structured SAP inventory architecture across WIP, QA Hold, RTV, and rework locations, improving material control.
Drove Lean initiatives via Kaizen and Gemba events, reducing lead times and improving material flow.
Supported enterprise SAP ERP deployment for ORA and LenSx surgical platforms, governing part number mapping, BOM structures, and workstation-level consumption.
Led packaging redesign from wood crating to corrugated, cutting unit cost by $70 and improving throughput by 75%.
Designed and deployed Kanban inventory systems with buffer controls, increasing material availability and reducing line interruptions.
Coordinated cross-functional verification and validation of packaging changes with Quality, Regulatory Affairs, and Packaging Engineering.
Presbia
Manufacturing Engineer II · Contract
Irvine, CA
Mar 2017 – Nov 2017
Designed manufacturing fixtures in SolidWorks to improve production efficiency and repeatability.
Developed and executed IQ/OQ/PQ validation protocols for a Tyvek pouch sealing process in a regulated environment.
Engineered packaging for a lens inserter and managed external vendors through validation testing.
Citco
Manufacturing Engineer I · Contract
Walnut, CA
Feb 2016 – Jan 2017
Designed and implemented a pneumatic lip balm extraction system, reducing downtime by 65%.
Supported installation and commissioning of an Allen-Bradley PLC automated assembly line for high-volume production, including controls checkout and line prove-out.
Authored PFMEA documentation for an automated filling line to strengthen risk identification and process control.