Andrew Krawec Email & Phone Number

Chapel Hill, Nc, Us

Durham, Nc

Baebies offers a solution for early disease detection and comprehensive diagnostics through screening and testing platforms powered by a digital microfluidic platform. The products consist of a lab-on-a-chip disposable and diagnostic instrument.Personal highlights include:• Performs administrative QMS activities including documentation control, assigning training, and facilitating quality processes.• Plans and executes internal quality audits checking compliance to ISO 13485:2016… Show more Baebies offers a solution for early disease detection and comprehensive diagnostics through screening and testing platforms powered by a digital microfluidic platform. The products consist of a lab-on-a-chip disposable and diagnostic instrument.Personal highlights include:• Performs administrative QMS activities including documentation control, assigning training, and facilitating quality processes.• Plans and executes internal quality audits checking compliance to ISO 13485:2016, FDA CFR 21 part 820, and IVDR 2017/746.• Leads quality and product sustaining activities including CAPAs, Change Controls, Root Cause Investigations, and design quality reviews. Show less

Durham, North Carolina, United States

• Provided expertise for integration efforts to combine electromechanical, disposable, and software systems for a Class-2 diagnostic device.• Authored and maintained engineering documentation including protocols, DHFs, SOPs, project reports, and product requirements. • Acted as project manager for a large software update, utilizing PM tools and managing budget and labor for several functional groups.• Directed product failure testing including DOE, scheduling resources, organizing… Show more • Provided expertise for integration efforts to combine electromechanical, disposable, and software systems for a Class-2 diagnostic device.• Authored and maintained engineering documentation including protocols, DHFs, SOPs, project reports, and product requirements. • Acted as project manager for a large software update, utilizing PM tools and managing budget and labor for several functional groups.• Directed product failure testing including DOE, scheduling resources, organizing data, and communicating outcomes to stakeholders.• Drove the implementation of changes to product design, functionality, and intractability based on customer and internal feedback.• Designed and executed studies evaluating end-user usability, product performance, and reliability that leveraged statistical analysis tools.• Qualified, calibrated, and released greater than $300,000 of biomedical instrumentation per quarter across two product families.• Supported the software and firmware development cycle through bug-finding, stress testing, and Verification and Validation. Show less

Round Lake, Illinois, United States

Promoted to Engineer I for performing high-quality engineering documentation work, having a strong grasp of QMS and sustaining documentation needs, and leading several engineering studies and investigations on core portfolio products.Highlights include:-Supported development and testing of Peritoneal Dialysis medical devices, components, and disposables. -Informed Design Owners on appropriate, risk-aware experimental design for effective utilization of limited testing resources… Show more Promoted to Engineer I for performing high-quality engineering documentation work, having a strong grasp of QMS and sustaining documentation needs, and leading several engineering studies and investigations on core portfolio products.Highlights include:-Supported development and testing of Peritoneal Dialysis medical devices, components, and disposables. -Informed Design Owners on appropriate, risk-aware experimental design for effective utilization of limited testing resources. -Enabled Rapid Prototyping functions including feasibility testing and materials selection for product exploratory studies. -Earned BaxSTAR award for managing a Human Factors study for production and implementation of PPE at manufacturing facilities. -Lab Manager – responsible for general laboratory activities including asset calibration, EH&S inspections, and equipment training. Show less

Round Lake, Illinois, United States

-Characterized plastics and adhesives used in solution and drug packaging using mechanical testing -Implemented Good Laboratory Practices to adhere to internal and federal regulations and protocols -Documented experimental results using appropriate documentation guidelines and practices

West Lafayette

•Created microfluidic devices for the synthesis of polylactic acid crystals in high temperature solutions•Designed cost-effective fluid pump systems for use in introductory educational lab settings•Developed educational resources for secondary and postsecondary educators to introduce microfluidic and hydrodynamic fundamentals to students•Researching imaging and analysis techniques for fabricating metal oxide-based Janus particles

West Lafayette

• Developed software for comparing ceramic crystalline microscopy and diffractometry • Designed and documented a tool for academic use on the NanoHUB online tool database • Authored and presented research findings and results at Purdue SURF and NanoHUB symposia

Henderson, Ky

• Collaborated with production associates to implement 5S and lean manufacturing standards• Implemented the Red-Tag system for standardizing inventory logistics and workspace organization • Reviewed feedback from supervisors and team members to improve workflow processes• Participated in quality study addressing part rejection; created visuals for improving process control• Professionally presented information to management and associates in a clear and engaging manner