Brian Bukala Email & Phone Number

California, United States

Minneapolis, MN, US

• Led and grew an engaged Design Quality Engineering, Reliability, and Risk Management team responsible for the safety, effectiveness, and reliability of life-sustaining ventilator families throughout their product.
• Being recognized as an accomplished and effective leader, Medtronic has promoted me three times:o Senior Design Quality Engineering Manager – Nov 2023o Senior Principal Design Quality Engineer – Dec 2020o Principal.
• Effectively presented technical analyses and opinions to senior leadership as the OU’s Risk Management and Software SME during business-critical Benefit-to-Risk Assessment, FCA, 510(k), and acquisition decisions, and.
• Provided review, approval, and broad oversight for all aspects of product design, including software, mechanical, electrical, and labeling subsystems, from concept to post-market phases, with keen focus on risk.
• Gained a reputation for devising flexible yet compliant, success-oriented solutions, based on deep subject matter knowledge, creativeness, critical thinking, and expert engineering judgement.
• Ensured successfully defended compliance with the following primary set of regulations and standards, as well as Medtronic's extensive and mature multi-layered QMS:o 21 CFR Parts 820 (QSR) and 806 (Reporting)o EU.

US

• Enjoyed a planned sabbatical away from industry to develop new skills and satisfy personal interests:
• Authored two novels and a non-fiction book, thereby sharpening my written communication skills.
• Developed professional-level expertise with the LAMP stack (Linux, Apache, MySQL, and Perl) while designing, documenting, testing, and administrating automated, database-driven network applications.

• Led ten engineers to accomplish software system design verification during the iterative/Agile development of a networked, interoperable medication-management (infusion) system:
• Represented the test team during core-team meetings comprised of project and program management, software development, marketing, clinical affairs, quality assurance, regulatory affairs, and technical writing functions.
• Created and approved SDLC deliverables, including user needs and product requirements, system and software subsystem specifications, test plans, test procedures, test reports, risk analyses, anomaly descriptions and.
• Performed automated software unit testing and requirement-based testing (including black-box, white-box, negative path, system integration, compatibility, and ad-hoc approaches), and intended-use validation of.

Lake Forest, IL, US

• Managed all aspects of software tool and automated-process validation within a globally regulated software development center:
• Led a team of engineers in order to validate software tools and automated processes (~ 50/year) intended to improve the quality and efficiency of our medical device software development and testing lifecycles.
• Simplified the existing tool validation process by creating a procedure and templates.
• Devised, implemented, and administrated an electronic Design History File (eDHF) employing the Perforce configuration management system to consolidate, control, and archive project deliverables.
• Devised, implemented, and administrated a project tracking solution employing DevTrack in order to better manage and track many concurrent tool validation projects.
• Played a key role in the design, validation, and implementation of an automated software build system.

• Performed design verification and validation of mechanical, electrical, and software subsystems for a regulated In-Vitro Diagnostics company:
• Performed hands-on troubleshooting, modification, and repair of a variety of prototype electro-mechanical devices and software that make up a fully automated infectious microorganism testing system, while maintaining.
• Provided failure root-cause analyses, recommendations for design fixes, and engineering solutions for many R&D challenges.
• Designed, documented, and executed specification-based testing using validated Visual Basic scripts and LabView software.
• Invented, fabricated, and validated custom mechanical and electrical testing devices, fixtures, tools, and processes.

• Completed numerous Computer Aided Design (CAD) projects for clients such as the California Department of Transportation (Caltrans) and the City of San Diego, as an associate within a private landscape architecture firm:
• Served as technical lead for mathematical calculations, documentation templates, and the advanced utilization of MicroStation CAD software.
• Designed and implemented various templates and SOPs to simplify business activities, computing, and design.

• Managed large metropolitan electric utility construction projects, as the single point of customer contact responsible for taking them from the proposal stage to completion:
• Designed and oversaw the construction of expanded electrical utility infrastructure—totaling more than $5 million in capital investment¬—including new underground civil structures and electrical circuitry ranging from.
• Managed construction by coordinating a diverse group of professionals (city officials, attorneys, engineering firms, representatives from other affected utilities, equipment vendors, construction foremen, and private.
• Designed construction prints using MicroStation CAD software, performed analytic and computational circuit analyses, produced cost estimates, planned strategies with senior internal management, held bid meetings.
• Promoted an improved culture of safety and quality through careful and more robust designs and daily two-way dialogues with the hands-on construction crews in order to discuss their construction techniques, equipment.

Upton, NY, US

• Operated the Collider/Accelerator complex used for high-energy particle physics research, funded by the U.S. Department of Energy:
• Used an assortment of custom computer hardware and software applications to configure, operate, troubleshoot, and optimize the Collider/Accelerator complex from the Main Control Room in order to achieve the beam.
• Assisted Ph.D. physicists and gained experience in state-of-the-art RF systems, high-voltage and pulsed power supplies, power generation and storage, electro-magnetic devices, cooling systems, optical technology.
• Directed, from Main Control, a multi-disciplinary team effort to quickly recover from operational crises such as power dips or critical equipment failures in order to maximize complex up-time.
• Proposed, designed, and executed beam optimization experiments, performed data collection, and completed complex analytical calculations to achieve a more consistent and denser beam.
• Played a key role in the commissioning of the laboratory’s newest collider (the Relativistic Heavy Ion Collider [RHIC]) by designing and validating a radiation-monitoring software application ahead of schedule.