Carlos Clemente Cruz is a seasoned engineer with over 25 years of experience in the medical device industry, specializing in the development of Endovascular, Neurovascular, and Cardiovascular Guidewires and Catheters. His career spans engineering roles in R&D, Quality, and Manufacturing/Process Engineering to Management Represenatitive.
In R&D, he initiated his career at Cordis (a J&J Co.) in 1996, introducing novel endovascular guidewires and capturing additional market shares. He transitioned to Manufacturing, supporting all of Cordis Guidewire manufacturing from Centerless Grinding to Packaging, and transferred Stent drug coating processes from NJ to FL.
In Manufacturing/Process Engineering at Boston Scientific since 2002, he provided technical support for transferring products from R&D to Production, duplicated production lines for transfer to Costa Rica, and wrote and updated Assembly Drawing, IQ, OQ, and PQ as part of the manufacturing transfer process.
Since 2011, he has been part of the Quality organization, starting as an R&D Quality Engineer for Biomet, transitioning to a Supplier Quality Engineering role, and gaining his ASQ Quality Auditing Certification. He moved to a management position at Cerenovous (a J&J Co.), responsible for Receiving Inspection and Quality Control. In 2023, he began directing the Quality group of East End Medical I, supporting the manufacture of Steerable Balloon Catheter Systems, launching new products, and managing internal/external audits. As well as Representing Management by ensuring implementation and maintenance of key standards and guidelines and reporting back to top management on performance metrics.
His career is marked by a commitment to excellence, continuous improvement, and a unique perspective from his expertise in Project Management and Validation of processes.
He has leveraged his expertise to aid companies, acquiring a practitioner’s level of knowledge and experience in the following areas:
• Characterization and validation of equipment/processes within industries regulated by the FDA and ISO.
• Development and application of guidewires and catheter-based technology for Cardiology, Endovascular, and Neurovascular treatments.
• Comprehensive understanding of Quality, Manufacturing, R&D, Design Control, Process & Project Management, Product lifecycle, FDA requirements, Commercialization of products, Verification & Validation (V&V), Risk Management, ISO:13485, Product Testing, Failure Mode, and Effects Analysis (FMEA), Prototyping, and Radiofrequency (RF) Ablation.
• Creation and updating of Risk Management File documents, including Risk Management Plan/Report, Design Failure Mode, and Effects Analysis (DFMEAs), and Process Failure Mode and Effects Analysis (PFMEAs).
• Leadership experience in Quality Systems Management, specifically overseeing the Receiving Inspection/Quality Control Department, and conducting Internal and External Audits in compliance with standards such as ISO9001/13485 Design Control, and Quality System Regulation (QSR - 21 CFR820).
Certifications:
● Six Sigma Belt Trained (2004)
● ASQ Certified Quality Auditor (2012)
● ISO 13485:2016 Lead Auditor (2022)
WORK EXPERIENCE
Director of Quality (Management Representative); East End Medical I, Miramar FL Jan 2023 to Present
Sr Quality Engineer/ Auditor; Zim Vie, Palm Beach Gardens FL Sep 2021 to Jan 2023
Sr Quality Engineer/ QC Supervisor; Cerenovus (a J&J Company), Miramar FL Nov 2013 to Sep 2021
Sr Quality Engineer; Biomet3i, Palm Beach Gardens FL May 2011 to Nov 2013
Sr Mechanical Engineer; Motorola Solutions, Plantation, FL May 2007 to Nov 2011
Process Engineer II; Boston Scientific, Doral, FL Nov 2002 to Nov 2007
Medical Device Project Manager, Crisp Medical Fort Lauderdale, FL Jan 2001 to Nov 2002
MFG/Process Engineer; Cordis (a J&J Company), Miami Lakes FL Nov 1996 to Jan 2001
EDUCATION
University of Florida, Gainesville, FL B.S in Mechanical Engineering (1995)