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I am a Senior Project Engineer and SME with 15+ years of experience in medical device, aerospace, and defense industries. I lead cross-functional teams, drive regulatory compliance (FDA ISO, EU MDR, MDSAP), and own Design Controls, V&V, and Quality Risk Management from concept through market release. I have a proven track record in remediating FDA 483s, aligning with DoD programs, and delivering robust, user-friendly products that meet stringent safety and quality standards. I thrive in complex, fast-paced environments and excel at bridging engineering, manufacturing, quality, and regulatory to achieve reliable, repeatable designs with robust risk management. My goal is to design with about 90% confidence and 95% reliability for acceptance testing, ensuring strong customer satisfaction for safety, UDI, and IFU across global markets.…I am a Senior Project Engineer and SME with 15+ years of experience in medical device, aerospace, and defense industries. I lead cross-functional teams, drive regulatory compliance (FDA ISO, EU MDR, MDSAP), and own Design Controls, V&V, and Quality Risk Management from concept through market release. I have a proven track record in remediating FDA 483s, aligning with DoD programs, and delivering robust, user-friendly products that meet stringent safety and quality standards. I thrive in complex, fast-paced environments and excel at bridging engineering, manufacturing, quality, and regulatory to achieve reliable, repeatable designs with robust risk management. My goal is to design with about 90% confidence and 95% reliability for acceptance testing, ensuring strong customer satisfaction for safety, UDI, and IFU across global markets.

Art Muñoz

Project Manager, QA Engineer, Product Designer, +2

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I am a Senior Project Engineer and SME with 15+ years of experience in medical device, aerospace, and defense industries. I lead cross-functional teams, drive regulatory compliance (FDA ISO, EU MDR, MDSAP), and own Design Controls, V&V, and Quality Risk Management from concept through market release. I have a proven track record in remediating FDA 483s, aligning with DoD programs, and delivering robust, user-friendly products that meet stringent safety and quality standards. I thrive in complex, fast-paced environments and excel at bridging engineering, manufacturing, quality, and regulatory to achieve reliable, repeatable designs with robust risk management. My goal is to design with about 90% confidence and 95% reliability for acceptance testing, ensuring strong customer satisfaction for safety, UDI, and IFU across global markets.…I am a Senior Project Engineer and SME with 15+ years of experience in medical device, aerospace, and defense industries. I lead cross-functional teams, drive regulatory compliance (FDA ISO, EU MDR, MDSAP), and own Design Controls, V&V, and Quality Risk Management from concept through market release. I have a proven track record in remediating FDA 483s, aligning with DoD programs, and delivering robust, user-friendly products that meet stringent safety and quality standards. I thrive in complex, fast-paced environments and excel at bridging engineering, manufacturing, quality, and regulatory to achieve reliable, repeatable designs with robust risk management. My goal is to design with about 90% confidence and 95% reliability for acceptance testing, ensuring strong customer satisfaction for safety, UDI, and IFU across global markets.

Available to hire

I am a Senior Project Engineer and SME with 15+ years of experience in medical device, aerospace, and defense industries. I lead cross-functional teams, drive regulatory compliance (FDA ISO, EU MDR, MDSAP), and own Design Controls, V&V, and Quality Risk Management from concept through market release. I have a proven track record in remediating FDA 483s, aligning with DoD programs, and delivering robust, user-friendly products that meet stringent safety and quality standards.

I thrive in complex, fast-paced environments and excel at bridging engineering, manufacturing, quality, and regulatory to achieve reliable, repeatable designs with robust risk management. My goal is to design with about 90% confidence and 95% reliability for acceptance testing, ensuring strong customer satisfaction for safety, UDI, and IFU across global markets.

Skills

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Experience Level

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Intermediate

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Intermediate

Work Experience

Senior Project Engineer / Sr. Product Design Engineer at Safeguard/Combat Medical

June 1, 2025 - June 1, 2025

Directed engineering transition following acquisition of AutoMedx into Safeguard Medical DoD ventilator systems. Remediated FDA 483 observations and improved MDSAP documentation aligning with FDA and ISO standards. Led cross-functional collaboration with Engineering, Manufacturing, Quality, and Regulatory Affairs to strengthen project execution through Lean Manufacturing, Six Sigma, Kaizen, and 5S clean-up. Implemented design inputs that enhanced profitability and ensured patient safety.

Senior Design Quality Engineer (DQE) at RQM+

June 1, 2023 - June 1, 2023

Managed remediation of critical care respiratory devices impacted by four FDA observations to MDSAP. Ensured compliance with EU MDR 2017/745 and FDA design controls across multiple Class II and III devices. Executed gap analyses on Technical Files and delivered corrective actions for IVDR diagnostic device reviews. Partnered with global teams (Switzerland, England, U.S.) on design controls, CAPA closure, and V&V testing.

Principal Manufacturing Engineer, NPD/R&D at Neurolens

May 1, 2021 - May 1, 2021

Spearheaded development of a revolutionary vision diagnostic device from concept to market release to MDSAP. Authored and executed Design Development Plans (DDPs), V&V test protocols, and manufacturing processes. Contributed to establishment of QMS compliance system for labeling UDI & IFU.

Senior Design Quality Engineer (DQE) at Zimmer Biomet

May 1, 2019 - May 1, 2019

Remediated Class III orthopedic devices under MDSAP/FDA 483 Consent Decree. Implemented Lean Kaizen, Six Sigma, 5S. Led CAPA investigations, V&V testing, and sterilization validations for gamma-sterilized implants. Ensured alignment of risk management processes for ISO 14971 & FDA 21 CFR 820 for labeling UDI & IFU.

Senior Design Quality Engineer (DQE) at IL Instrument Laboratory

November 1, 2018 - November 1, 2018

Oversaw design controls and V&V activities for Class III to MDSAP for In-Vitro diagnostic (IVDR) devices. Conducted gap analyses and remediated compliance issues in Technical Files and DHFs labeling UDI & IFU. Supported gamma & EtO sterilization validations for diagnostic equipment. Lean Kaizen, Six Sigma, 5S.

Senior Design Quality Engineer (DQE) at Terumo Cardiovascular Systems

April 1, 2016 - April 1, 2016

Managed risk assessments, CAPA remediation, and test methods for Class III heart transplant devices to MDSAP. Ensured full compliance with FDA 483 requirements, ISO standards, and EU MDR 2017/745.

Senior Principal Design Quality Engineer (DQE) at Masimo Corporation

September 1, 2015 - September 1, 2015

Supported design controls, risk management, and regulatory remediation for Class II pulse oximeters to MDSAP. Led CAPA/NCR closure related to Gamma and EtO sterilization using Lean Kaizen, Six Sigma, 5S. Collaborated with executive leadership on product performance, audits, and labeling UDI & IFU.

Project / Operations Manager at Silicon Kinetics

September 1, 2011 - September 1, 2011

Directed start-up operations for an award-winning IVDR diagnostic platform using Lean Kaizen, Six Sigma, 5S. Established manufacturing line, developed supply chain, and implemented ERP/MRP systems and UDI & IFU. Served as single point of accountability for design, manufacturing, quality, and regulatory readiness to MDSAP.

Aerospace & Defense Projects at Boeing, McDonnell Douglas, Hughes, Northrop Grumman

December 31, 2008 - December 31, 2008

Contributed to International Space Station, Delta Rockets, F-14 Tomcat, AWACS, and missile defense systems. Specialized in PCBAs, wire harnesses, mechanical/electrical assemblies, and RF radar systems. Held Secret Clearance; ensured compliance with DoD and FAA requirements for critical defense systems.