Zaragoza Briseno Jr.
Vice President Operations at TriSalus Life Sciences- Claim this Profile
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English Native or bilingual proficiency
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Spanish Professional working proficiency
Topline Score
Bio
Credentials
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Johnson & Johnson Black Belt Trained – 2003
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Johnson & Johnson Green Belt Certified – 2001
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Experience
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TriSalus Life Sciences
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United States
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Biotechnology Research
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1 - 100 Employee
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Vice President Operations
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Oct 2017 - Present
Led coating process characterization and re-qualified the company’s flagship products as a result of a critical raw material failure. Successfully closed 4 CAPAs in 2018 and managed the closure of 3 additional CAPAs in 2019. Developed a team to commercialize 2 new products and supported the development of a Clinical Device in 2019. Supported successful execution of FDA Medical Device Single Audit Program (MDSAP) certification in 2018 and annual ISO 13485 recertification in 2018 and 2019. Executed and managed a $220,000 facility renovation in 2019. Managed the re-qualified a 1,500 square foot Class 8 cleanroom in 2019. Established a Core Competency pathway, by focusing on proprietary coating technologies. Managed on-site Operations during Covid-19 pandemic from 2000 to present. Managed an overall capacity improvement of 33% in 2021. Managed the development of subassemblies processes to improve throughput by 30 times in 2020. Assisted in the development and led the characterization of an electrostatic spinning system that increased capacity by 400% in 2022. Managed 3 Teacher Interns (2018, 2019, and 2020) and mentored 9 college students in the Colorado BioScience Association (2018, 2019, and 2020). Managed summer intern in 2021 and 2022. Re-qualified: 2018 Surefire Infusion System 021 - 120 cm – Surefire Medical Inc. 2018 Surefire Infusion System 021R - 150 cm – Surefire Medical Inc. 2018 Surefire Infusion System 025M - 120 cm – Surefire Medical Inc. 2018 Surefire Infusion System 025MR- 150 cm – Surefire Medical Inc. 2018 Surefire Infusion System 025L - 120 cm – Surefire Medical Inc. 2018 Surefire Infusion System 025LR - 150 cm – Surefire Medical Inc. Product Introduction: 2019 TriNav Infusion System - 120 cm – TriSalus Life Sciences 2019 TriNav Infusion System - 150 cm – TriSalus Life Sciences Clinical Products: 2020 TriSalus Infusion System – TriSalus Life Sciences Show less
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Process & Operations Consultant
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Austin, Texas Area
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Senior Principal Consultant
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Feb 2016 - Present
Apollo Endosurgery: Characterized and validated a Dry Heat Sterilization process for Lap-Band products. Led a team to complete all characterization works at the manufacturing facility. DJO Surgical: Performed Validation Summary documents reviewing the current validated state of DJO Surgical Equipment and processes. Apollo Endosurgery: Characterized and validated a Dry Heat Sterilization process for Lap-Band products. Led a team to complete all characterization works at the manufacturing facility. DJO Surgical: Performed Validation Summary documents reviewing the current validated state of DJO Surgical Equipment and processes.
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Micell Technologies, Inc.
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Medical Equipment Manufacturing
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1 - 100 Employee
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Principal Process Development Engineer
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Sep 2016 - Oct 2017
Successfully characterized and validated Belco Thermosealers, Zebra label printers, vacuum ovens, and an Instron for in-house manufacturing and at a contract manufacturer. Characterized a process to increase stent drug coating capacity by 50% while reducing cost of goods, decreasing defects, and increasing equipment reliability. Investigated reducing cycle time by reducing manufacturing footprint and removing unnecessary processes. Successfully characterized and validated Belco Thermosealers, Zebra label printers, vacuum ovens, and an Instron for in-house manufacturing and at a contract manufacturer. Characterized a process to increase stent drug coating capacity by 50% while reducing cost of goods, decreasing defects, and increasing equipment reliability. Investigated reducing cycle time by reducing manufacturing footprint and removing unnecessary processes.
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Apollo Endosurgery
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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Senior Principal Engineer
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Jul 2012 - Dec 2015
Successfully established a stable supply chain for OverStitch™ Endoscopic Suturing System for Apollo Endosurgery by transferring the processes to an external manufacturer. Led and managed transfer team, planned logistics of travel and works for execution of the OverStitch™ transfer. Worked closely with Tier I and Tier II suppliers to ensure a successful product and supply chain launch. The processes included Trumpf laser welding, pad printing, and assembly. Successfully completed the transfer on time and within budget. Led and managed a team of 6 employees to establish Apollo S.R.L. operations in Costa Rica, a 14,900 sq.ft. facility. Lead efforts to obtain the country Free Trade Zone status and environmental SETNA permits. Assisted in the equipment selection process, the facilities layout, the equipment export process, 4,000 sq.ft. cleanroom qualification, Dry Heat Sterilization process definition and qualification, and established the infra-structure for operations in Costa Rica. Worked with local suppliers and contractors to complete the manufacturing facility on time and within budget. Managed three on-site contractors to complete validation works. Assisted in establishing In-Coming Inspection for the facility. Products Launched: 2015 – LAP-BAND® Adjustable Gastric Banding System – Apollo Endosurgery 2015 – ORBERA® Intragastric Balloon System – Apollo Endosurgery 2014 – OverStitch™ Endoscopic Suturing System – Apollo Endosurgery http://alcalde.texasexes.org/2016/02/horns-up-in-costa-rica/ Show less
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ArthroCare Corporation
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Medical Equipment Manufacturing
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100 - 200 Employee
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Staff Process Engineer
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Jun 2008 - Jun 2012
Worked with R&D to develop mechanical and assembly processes for Spine related medical devices. Transferred improvement processes to the Costa Rican manufacturing site, sterilization assessments were included as part of the transfer. Provided technical support for R&D and manufacturing device components. Participated in Design Verifications, sterilization (E-Beam and Gamma) Dose Mapping. Led and managed Design Validations, Tier 1, Process Qualifications, and supported product launches in Costa Rica. Managed material qualifications and implemented the change in production. Products Launched: 2011 – Parallax® Contour® -enhanced Vertebral Augmentation Device – ArthroCare Corporation 2010 – Parallax® Contour® Convenience Kits – ArthroCare Corporation 2009 – Parallax® Cement Conduits – ArthroCare Corporation Show less
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Cordis
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Staff Technical Services Engineer
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Dec 2007 - Jun 2008
Performed Ethylene Oxide (EO) and Gamma Radiation annual re-qualifications for drug-eluting stent products and non-drug devices. Authored D-value, Natural Product Resistance Testing (NPRT), and EO Residual waiver justifications for product transfers, product modifications, and supplier changes.
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Staff Design Control Engineer
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Apr 2007 - Dec 2007
Performed Design Validation (DV) for JAPAN CYPHER® Sirolimus-eluting Stent Enhanced Manufacturing Process. Led design control elements for the JAPAN CYPHER® Sirolimus-eluting Stent Enhanced Manufacturing Process. Maintained the JAPAN CYPHER® Stent Device History File (DHF) and project file. Conducted Design Output, Design Verification and Validation / Design Technology Transfer, and ISS Readiness Design Reviews. Product Launched:2008 – CYPHER® Sirolimus-eluting Coronary Stent (Japan) – Cordis Cardiology Show less
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Staff Process Engineer
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Apr 2003 - Apr 2007
Product/Process Development: Conducted general experimentation, full factorial Design of Experiments (DOE), partial factorial DOE works, and process characterization of Sirolimus eluting rates for CYPHER® Sirolimus-eluting Coronary Stents. Performed studies for Sirolimus Overage determination. Performed numerous Shelf Life studies (Material Qualifications, Product Performance Qualification (PPQ), and In-Process Components) for the CYPHER® Sirolimus. Led the implementation of a manufacturing process for the reduction of drug-elution test failures, a net savings of $32 million over a 1-year period. Process Validation:Managed and led the US CYPHER® Supply Chains PPQs for San German, Puerto Rico; Beerse, Belgium; and Latina, Italy. Managed the US CYPHER® Supply Chain and JAPAN CYPHER® Supply Chain PPQ for San German, Puerto Rico for an extended shelf life manufacturing change. Qualified raw material suppliers, process parameters, and drug-coating process improvements. FDA Experience: Provided numerous works for FDA responses such as deposition of Parylene C coating, shelf life of In-Process components, stability data for various supply chain qualifications, and overage studies. Executed Corrective and Preventative Action (CAPA) file for drug-elution rates of CYPHER®. Interfaced with the FDA on the CAPA elution rate investigatory studies and qualifications during two separate on-site audits. Leadership: Lead various teams in the execution of a variety of experiments and protocols. Developed, mentored, and coached numerous Cordis associates. Product Launched:2003 – CYPHER® Sirolimus-eluting Coronary Stent (US) – Cordis Cardiology Show less
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Senior Process Engineer
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Aug 2002 - Apr 2003
Product/Process Development:Assisted in the process development of CYPHER® SELECT™ Sirolimus-eluting Stents for OUS. Developed process definition, process characterization, new process equipment introduction, and process implementation. The process implemented reduced the cycle time by half. Process Validation: Performed the CYPHER® SELECT™ Sirolimus-eluting Stents for OUS Performance Qualification (PQ). Assisted in the CYPHER® SELECT™ Sirolimus-eluting Stents PPQ. Product Launched:2003 – CYPHER® SELECT™ Sirolimus-eluting Coronary Stent (OUS) – Cordis Cardiology Show less
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Senior Process Engineer
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Mar 2002 - Aug 2002
Process Validation: Assisted in the site-to-site process transfer of the Parylene C coating process. Performed the Parylene C coating Performance Qualifications. Performed Installation Qualifications and Operation Qualifications (IQ/OQ) for ovens, Parylene C Coaters, and Spray Coating Equipment. Performed Spray Coating Process PQs. Leadership: Supported CYPHER® Sirolimus-eluting Coronary Stents Base Business. Assisted in Parylene C coating process training and process technical support. Product Launched:2002 – CYPHER® Sirolimus-eluting Coronary Stent (OUS) – Cordis Cardiology Show less
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Process Engineer II
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Oct 2000 - Mar 2002
Supported the product and process development of a next generation neurocatheter. Performed a variety of DOEs and process characterization for process optimization. Reduced cycle time by 50%. Performed the process validation in the form of a PPQ. Product Launched:2001 – PROWLER® SELECT™ LP Microcatheter – Cordis Neurovascular
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Ford Motor Company
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United States
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Motor Vehicle Manufacturing
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700 & Above Employee
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Engineering Fellow
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May 1998 - Aug 1998
Responsible for the functionality of a computer simulation-modeling program that simulated vehicle automatic transmissions. Verified the simulation-modeling program to actual transmission performances for program accuracy. Responsible for the functionality of a computer simulation-modeling program that simulated vehicle automatic transmissions. Verified the simulation-modeling program to actual transmission performances for program accuracy.
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Ford Motor Company
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United States
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Motor Vehicle Manufacturing
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700 & Above Employee
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Engineering Fellow
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May 1997 - Aug 1997
Fitted Ford manufactured vehicles in accordance with country safety and import specifications for product penetration into foreign markets. Modified the Crown Victoria exterior for the European market. Addressed Ford Mustang exterior design for the Korean market. Assisted in the re-design of the floor pan of the Ford Expedition for the Russian market. Fitted Ford manufactured vehicles in accordance with country safety and import specifications for product penetration into foreign markets. Modified the Crown Victoria exterior for the European market. Addressed Ford Mustang exterior design for the Korean market. Assisted in the re-design of the floor pan of the Ford Expedition for the Russian market.
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IBM
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United States
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IT Services and IT Consulting
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700 & Above Employee
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Manufacturing Engineering / New Process Development
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Mar 1996 - May 1997
Supported operations in the photolithographic process for Printed Circuit Board (PCB) manufacturing. Implemented Statistical Process Controls (SPC) for the inner layer production process. Led development work for Buried Capacitance (BC) and Impedance products. Developed and implemented a production process for TCP anti-burst. The implementation of the TCP anti-burst process resulted in a 97% yield and an annual savings of $1.5 million. Supported operations in the photolithographic process for Printed Circuit Board (PCB) manufacturing. Implemented Statistical Process Controls (SPC) for the inner layer production process. Led development work for Buried Capacitance (BC) and Impedance products. Developed and implemented a production process for TCP anti-burst. The implementation of the TCP anti-burst process resulted in a 97% yield and an annual savings of $1.5 million.
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Education
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1997 - 2000
The University of Texas at Austin
Master of Science (MS), Mechanical Engineering -
1990 - 1995
The University of Texas at Austin
Bachelor of Science (BS), Mechanical Engineering
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