Kyle Fontes
Mechanical Engineer III at TransMedics, Inc.- Claim this Profile
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English Native or bilingual proficiency
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Portuguese Native or bilingual proficiency
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Bio
Liam Brady
I am grateful for the opportunity to write this letter of recommendation for Kyle. Without reservation I write that Kyle is a truly exceptional candidate, effective team member and valuable resource, always aligned to the department and company goals. Kyle’s easy-to-be-with personality is appropriately coupled with a genuine focus and commitment to results – collective and individual. His strong and growing knowledge base affords him effective relationships within his team and cross functionally. Kyle is quickly respected, always respectful, and demonstrates responsibility inordinately for a person at this point in their career. Rarely have I met someone at this point in their career who also has Kyle’s ability to understand the environment, to determine the key opportunities, to communicate clearly and to realize those opportunities. My closest work with Kyle was during the infancy of a production environment that I am still responsible for now three years later. The line was developed as the company’s validated process to deliver product in support of the release of the next generation of our medical device. Kyle successfully wrote and coordinated the release of the core manufacturing Standard Operating Procedure (SOP). Kyle’s procedure integrated the Operator’s perspective, material movement, cycle time, product software, data collection scanners, selection of product variant, mechanical motion, sensor/data acquisition, and overall equipment/product reliability. The SOP still retains the approach and steps that Kyle documented on the first revision, and is used every day. During this work Kyle also trained the Operators on the correct execution and explained why the process was designed as it is, setting them up to achieve the demanding production targets. Kyle enjoyed this role as trainer and consultant to the team, also enabling career development for Operators and Team Leaders. The area has been audited by FDA representatives during routine audits, with no findings. Perhaps more importantly, to this day there has never been a field Patient quality complaint attributed to any aspect of this production process. I was also pleased to see Kyle not only contribute to other areas of the business, but expanding his understanding of other departments and how they connect. Kyle subsequently led the company’s calibration program. Focusing on our class-2 electro-mechanical and high-volume device, Kyle was later engaged with Lifecycle Engineering on qualifying new batteries and on executing design V&V of cost-reduced PCBA. This work took Kyle into areas of troubleshooting product, using lab tools, writing procedures/GDP, and root-cause processes. I have hired and led thousands of technical and other professionals, and run large successful technical production areas in growing and respected companies. It is clear to me that Kyle has vast potential to contribute and lead transformative improvement wherever he takes his career. -Liam Brady. wbrady@in
Liam Brady
I am grateful for the opportunity to write this letter of recommendation for Kyle. Without reservation I write that Kyle is a truly exceptional candidate, effective team member and valuable resource, always aligned to the department and company goals. Kyle’s easy-to-be-with personality is appropriately coupled with a genuine focus and commitment to results – collective and individual. His strong and growing knowledge base affords him effective relationships within his team and cross functionally. Kyle is quickly respected, always respectful, and demonstrates responsibility inordinately for a person at this point in their career. Rarely have I met someone at this point in their career who also has Kyle’s ability to understand the environment, to determine the key opportunities, to communicate clearly and to realize those opportunities. My closest work with Kyle was during the infancy of a production environment that I am still responsible for now three years later. The line was developed as the company’s validated process to deliver product in support of the release of the next generation of our medical device. Kyle successfully wrote and coordinated the release of the core manufacturing Standard Operating Procedure (SOP). Kyle’s procedure integrated the Operator’s perspective, material movement, cycle time, product software, data collection scanners, selection of product variant, mechanical motion, sensor/data acquisition, and overall equipment/product reliability. The SOP still retains the approach and steps that Kyle documented on the first revision, and is used every day. During this work Kyle also trained the Operators on the correct execution and explained why the process was designed as it is, setting them up to achieve the demanding production targets. Kyle enjoyed this role as trainer and consultant to the team, also enabling career development for Operators and Team Leaders. The area has been audited by FDA representatives during routine audits, with no findings. Perhaps more importantly, to this day there has never been a field Patient quality complaint attributed to any aspect of this production process. I was also pleased to see Kyle not only contribute to other areas of the business, but expanding his understanding of other departments and how they connect. Kyle subsequently led the company’s calibration program. Focusing on our class-2 electro-mechanical and high-volume device, Kyle was later engaged with Lifecycle Engineering on qualifying new batteries and on executing design V&V of cost-reduced PCBA. This work took Kyle into areas of troubleshooting product, using lab tools, writing procedures/GDP, and root-cause processes. I have hired and led thousands of technical and other professionals, and run large successful technical production areas in growing and respected companies. It is clear to me that Kyle has vast potential to contribute and lead transformative improvement wherever he takes his career. -Liam Brady. wbrady@in
Liam Brady
I am grateful for the opportunity to write this letter of recommendation for Kyle. Without reservation I write that Kyle is a truly exceptional candidate, effective team member and valuable resource, always aligned to the department and company goals. Kyle’s easy-to-be-with personality is appropriately coupled with a genuine focus and commitment to results – collective and individual. His strong and growing knowledge base affords him effective relationships within his team and cross functionally. Kyle is quickly respected, always respectful, and demonstrates responsibility inordinately for a person at this point in their career. Rarely have I met someone at this point in their career who also has Kyle’s ability to understand the environment, to determine the key opportunities, to communicate clearly and to realize those opportunities. My closest work with Kyle was during the infancy of a production environment that I am still responsible for now three years later. The line was developed as the company’s validated process to deliver product in support of the release of the next generation of our medical device. Kyle successfully wrote and coordinated the release of the core manufacturing Standard Operating Procedure (SOP). Kyle’s procedure integrated the Operator’s perspective, material movement, cycle time, product software, data collection scanners, selection of product variant, mechanical motion, sensor/data acquisition, and overall equipment/product reliability. The SOP still retains the approach and steps that Kyle documented on the first revision, and is used every day. During this work Kyle also trained the Operators on the correct execution and explained why the process was designed as it is, setting them up to achieve the demanding production targets. Kyle enjoyed this role as trainer and consultant to the team, also enabling career development for Operators and Team Leaders. The area has been audited by FDA representatives during routine audits, with no findings. Perhaps more importantly, to this day there has never been a field Patient quality complaint attributed to any aspect of this production process. I was also pleased to see Kyle not only contribute to other areas of the business, but expanding his understanding of other departments and how they connect. Kyle subsequently led the company’s calibration program. Focusing on our class-2 electro-mechanical and high-volume device, Kyle was later engaged with Lifecycle Engineering on qualifying new batteries and on executing design V&V of cost-reduced PCBA. This work took Kyle into areas of troubleshooting product, using lab tools, writing procedures/GDP, and root-cause processes. I have hired and led thousands of technical and other professionals, and run large successful technical production areas in growing and respected companies. It is clear to me that Kyle has vast potential to contribute and lead transformative improvement wherever he takes his career. -Liam Brady. wbrady@in
Liam Brady
I am grateful for the opportunity to write this letter of recommendation for Kyle. Without reservation I write that Kyle is a truly exceptional candidate, effective team member and valuable resource, always aligned to the department and company goals. Kyle’s easy-to-be-with personality is appropriately coupled with a genuine focus and commitment to results – collective and individual. His strong and growing knowledge base affords him effective relationships within his team and cross functionally. Kyle is quickly respected, always respectful, and demonstrates responsibility inordinately for a person at this point in their career. Rarely have I met someone at this point in their career who also has Kyle’s ability to understand the environment, to determine the key opportunities, to communicate clearly and to realize those opportunities. My closest work with Kyle was during the infancy of a production environment that I am still responsible for now three years later. The line was developed as the company’s validated process to deliver product in support of the release of the next generation of our medical device. Kyle successfully wrote and coordinated the release of the core manufacturing Standard Operating Procedure (SOP). Kyle’s procedure integrated the Operator’s perspective, material movement, cycle time, product software, data collection scanners, selection of product variant, mechanical motion, sensor/data acquisition, and overall equipment/product reliability. The SOP still retains the approach and steps that Kyle documented on the first revision, and is used every day. During this work Kyle also trained the Operators on the correct execution and explained why the process was designed as it is, setting them up to achieve the demanding production targets. Kyle enjoyed this role as trainer and consultant to the team, also enabling career development for Operators and Team Leaders. The area has been audited by FDA representatives during routine audits, with no findings. Perhaps more importantly, to this day there has never been a field Patient quality complaint attributed to any aspect of this production process. I was also pleased to see Kyle not only contribute to other areas of the business, but expanding his understanding of other departments and how they connect. Kyle subsequently led the company’s calibration program. Focusing on our class-2 electro-mechanical and high-volume device, Kyle was later engaged with Lifecycle Engineering on qualifying new batteries and on executing design V&V of cost-reduced PCBA. This work took Kyle into areas of troubleshooting product, using lab tools, writing procedures/GDP, and root-cause processes. I have hired and led thousands of technical and other professionals, and run large successful technical production areas in growing and respected companies. It is clear to me that Kyle has vast potential to contribute and lead transformative improvement wherever he takes his career. -Liam Brady. wbrady@in
Credentials
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CSWP Subject Exams - Surfacing, Sheet Metal, Drawing Tools, Weldments
Dassault SystèmesMay, 2022- Nov, 2024 -
CSWP: Certified Solidworks Professional - Mechanical Design
Dassault SystèmesOct, 2021- Nov, 2024 -
Lean Six Sigma Yellow Belt
GBMP & The Northeast Lean ConferenceFeb, 2021- Nov, 2024 -
CPR/AED/First Aid
American Heart AssociationOct, 2022- Nov, 2024 -
IPC-A-610 Specialist - Acceptability of Electronic Assemblies
IPCJul, 2022- Nov, 2024
Experience
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TransMedics, Inc.
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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Mechanical Engineer III
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Oct 2023 - Present
Member of the sustaining engineering team supporting TransMedics's Organ Care System, a revolutionary technology that mirrors human physiology and preserves organs used in the treatment of end-stage heart, lung, and liver failure. The Organ Care System increases organ utilization, improves patient outcomes, and reduces transplant costs. Member of the sustaining engineering team supporting TransMedics's Organ Care System, a revolutionary technology that mirrors human physiology and preserves organs used in the treatment of end-stage heart, lung, and liver failure. The Organ Care System increases organ utilization, improves patient outcomes, and reduces transplant costs.
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ZOLL Medical Corporation
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Mechanical Engineer II
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Sep 2021 - Sep 2023
Supported sustaining engineering activities for projects related to component obsolescence, manufacturing issues, new injection mold tooling, compliance gaps, ppv cost reductions, and customer complaint reductions. Products supported included: AEDs, patient monitors, ventilator/aspirator, chargers, cables, and adapters. Supported sustaining engineering activities for projects related to component obsolescence, manufacturing issues, new injection mold tooling, compliance gaps, ppv cost reductions, and customer complaint reductions. Products supported included: AEDs, patient monitors, ventilator/aspirator, chargers, cables, and adapters.
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Evident Scientific
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Electrical Equipment Manufacturing
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700 & Above Employee
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Manufacturing Engineer
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Jan 2021 - Aug 2021
Formerly Olympus IMS. Provided manufacturing continuous improvement support for high mix/low volume NDT ultrasonic probe production. Formerly Olympus IMS. Provided manufacturing continuous improvement support for high mix/low volume NDT ultrasonic probe production.
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Insulet Corporation
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Lifecycle Engineering Co-op
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Jun 2019 - Dec 2019
Performed and documented device testing on Insulet’s electro-mechanical pump (combination product) to support design changes, root cause investigations, and the qualification of new component suppliers.
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Calibration & PM Coordinator
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Jun 2017 - May 2019
Generated and tracked calibration recalls, preventative maintenance work orders, and scheduled service contractors.
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Manufacturing Intern
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May 2018 - Aug 2018
Supported DASH PDM (Personal Diabetes Manager) manufacturing launch through writing the process SOP, onboarding production operators and working as a production line leader during the initial weeks of production.
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Education
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University of Massachusetts Lowell
Bachelor of Science - BS, Mechanical Engineering -
University of Massachusetts Lowell
Master of Science - MS, Mechanical Engineering