Matt Sladicka Email & Phone Number

Tempe, Arizona, United States

Tempe, Arizona, United States

•Partnered with RA, Division QMS, and TJ QMS teams to create a change control process and significant change process that allowed for manual communication between two unique QMS systems. •Divisional Quality representative supporting Manufacturing transfer of Patient Care Product lines from Lakeland, Florida to Tijuana, Mexico.•Stryker Sustainability Solutions RAQA workstream owner/Business Process Expert on project Accelerate for Commercial ERP conversion from JDE to SAP.•Product Retirement Lead moving legacy patient care and surgical products to obsolescence.

Tempe, Arizona

Provide leadership, support, mentorship and direct management of eight Advanced Quality Engineers. These resources ensure product quality prior to product launch by generating the risk file, determining risk-based sample sizes for verification/validation, working with suppliers on Production Part Approval Process(PPAP) and representing quality in New Product Development (NPD) projects.• Supported team in the launch of Vascular, Surgical, and Patient Care medical devices.• Managed implementation of Division RA/QA initiatives. • Provided front room and backroom support for 3rd party audits (FDA, ISO13485, MDSAP) with zero findings for areas of responsibility.• Drove and maintained engagement of direct reports.• Developed training programs that advanced the understanding of quality principles.• Managed premarket quality budget.

Tempe, Az

Tempe, Az

Provide leadership, support, mentorship and direct management of seven Post Market Quality Engineers. These resources ensure product quality after initial product launch by approving post market quality investigations, generating Post Market Health Risk Assessment(PMHRA), maintaining risk files and addressing Nonconformance through the NC/CAPA system. •Facilitate teams in identifying root cause for the top 20% of pareto'd complaints resulting in one product line complaint rate being reduced by more than 30%.•Develop and report key quality metrics to drive quality and efficiency.•Experienced with operation, development and risk management of noninvasive, vascular and surgical class II medical devices.

Tempe, Az

Direct Management of six Post Market Surveillance Technicians ensuring compliance to medical device complaint handling requirements. Improving cycle time and quality of investigations for product-related customer complaints ensuring both internal and external customer satisfaction.• Supported the reduction of complaint investigation backlog by 90% by leading the initial startup of a new complaint lab including hiring personnel, sourcing of equipment, validation of equipment and validation of test methods • Managed the standardization of the complaint investigation process for the division in TrackWise.

Tempe, Az

Responsible for developing, revising and maintaining quality standards for product development in the reprocessing and remanufacturing of medical devices. Ensure that testing meets the requirements of ISO regulations, FDA regulations, and internal Design Control process. Support and manage the Advanced Quality Engineering technicians.•Created Hazard Harm List, Functional Analysis, Hazard Analysis, PFMEA, and process mapping for ECG Leads, and Deep Vein Thrombosis(DVT) prophylaxis devices.•Created validation protocols (IQ, OQ-E), Gage R&Rs, DOEs and performed statistical analysis for various non-invasive medical devices.•Six Sigma resource and Statistical Subject Matter Expert on the Global Validation Stats SME Team.

Santa Ana, Ca

Responsible for the development and implementation of new test methods and manufacturing processes for Intraocular Cataract Lenses (IOLs) and Phaco Emulsification Devices from engineering build through verification, validation and clinical build. Drives product development within the requirements of ISO regulations, FDA regulations, and internal product development process (PDP). R&D Division Functional Leader responsible for lean six sigma deployment. •Led a team containing Engineering, Regulatory, Quality, Clinical and Manufacturing through the DMAIC process and reduced the number of phaco handpiece returns from the field by 90%.•Created and executed validation protocols (IQ, OQ, PQ), Gage R&Rs, DOEs and performed statistical analysis for various invasive medical devices.•Reduced variability in the injection molding process by 80%.•Generated training material and presented R&D Leadership and Sponsor training. Mentored R&D six sigma green belts through the DMAIC process.

Maintained baseline defectivity levels for the gate module by implementing SPC controlled on-product KLA monitors to detect defect excursions. Reduced baseline defectivity levels by managing cross-functional continuous improvement teams. Set defectivity testing requirements for all Corrective Action Board engineering changes that occur in the gate process module.•Isolated root cause for defect excursions, applied containment, dispositioned non-conforming product in a Material Review Board, and worked with responsible process engineering department to identify short term and long term actions to prevent repeat occurrences.•Identified continuous improvement projects and managed cross functional teams to lower baseline defectivity. Some projects reduced defectivity at an inspection point by as much as 50% and increased baseline yield by more than 5%.•Reviewed Failure Analysis Reports to assist Quality department in isolating root cause for product returns so preventative actions could be implemented.•Trained Yield Enhancement Team on new software which contains CAD renderings of Photo Reticles. Use of software helped identify several design mistakes which was attributed to as much as 15% yield loss.

Sustained etch equipment in a manufacturing environment through utilization of SPC methods to control and improve etch processes. Worked with device engineering and yield enhancement to improve the Poly etch and Front End Oxide (FOX) etch processes to achieve industry benchmark yields. Optimized etch tool and process performance for reduced variation, improved process capability and improved product yield.•Qualified new AMAT DPS poly etch chambers and released into production by ensuring that outputs met Purchase Agreement requirements and had no adverse effect on parametric or yield. Implemented a new equipment modification which increased throughput by 20%.•Developed a methodology for monitoring and controlling etch tool defectivity performance by using an on-product defectivity monitor resulting in a savings greater than $100K/year. The method resulted in quick root cause identification for tool and integration defectivity issues and was later propagated across all Process Engineering Departments. •Qualified a modified capture ring on DPS Poly Chambers which eliminated backside helium faults and had a savings of $250K/year due to inline scrap reduction.•Utilizing DMAIC Methodology identified interactions between different FOX etch processes and separated them to eliminate process interaction variation in process output parameters.•Utilized and created Failure Detection Control Models to detect tool performance deviations and automatically shut equipment down as the deviation happens.•Created, maintained, and documented changes in all Poly and FOX etch specifications.•Mentored new engineers and process technicians in troubleshooting, risk assessment, SPC and process dynamics.

Responsible for development of characterized etch processes to be transferred into manufacturing factories. Required to design experiments, analyze data, solve problems, oversee daily process performance and ensure successful transfer. •Developed MIM Oxide Etch Process using a Screening Experiment and a Robust Design Experiment optimizing four separate output parameters to meet design requirements.•Completed development, characterization and transfer of 0.35 micron HBT CMOS process, MIM Process, and 0.5 micron BiCMOS etch process to a manufacturing factory.•Developed processes, procured equipment, and oversaw conversion of eight inch Si equipment for six inch GaAs production.•Designed an interfab communication tool making use of the Motorola’s intranet, Core directory and Oracle database that got propagated to all Motorola Semiconductor Factories Worldwide.•Installed Gasonics L3510 and a LAM4420 and through testing confirmed that the tool performance fulfilled the purchase agreement requirements before releasing to manufacturing.•Mentored intern on a broad range of semiconductor projects resulting in her accepting a full time process engineering position.

• Performed Aerospace engineering tasks as needed and defined by the Vice President of GEC Marconi Aerospace in Whippany, NJ. • Managed engineering changes on a drafting board.• Facilitated test equipment setup.• Produced Stress analysis and part selection for the F16 Canopy Actuator and on the 30 mm DELCO Gun Rotary Actuator.• Assisted in the CAD Drawing and gear analysis of the Fail Free Actuator.• GEC Marconi Aerospace is now broken up as part of BAE System Electronics Unlimitted and Finmeccanica.