Chris Hewitt
Principal Manufacturing Engineer at Nevro- Claim this Profile
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Bio
Credentials
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Lean Six Sigma Foundations
LinkedInFeb, 2021- Nov, 2024 -
Certified SolidWorks Professional
SolidWorksDec, 2009- Nov, 2024 -
CSWP-Mold Tools
Solidworks
Experience
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Nevro
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Principal Manufacturing Engineer
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Mar 2022 - Present
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Shockwave Medical
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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 Manufacturing Engineer
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Feb 2021 - Mar 2022
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Stryker
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Associate Manufacturing Engineering Manager
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Jan 2020 - Jan 2021
• Direct entire local MFG engineering team of four in completing engineering improvement projects on time for site shutdown and in supporting production to meet necessary goals for site shutdown• Engage in operation management meetings to ensure the site meets its production goals• Collaborate with production management to overhaul and restructure the CER manufacturing lines and the packaging lines to improve production efficiency which facilitated a 35% increase output for the primary product line and 5% increase output for overall site production• Execute three manufacturing transfer projects and qualification of two components at an alternative injection molding supplier in parallel within 1 year timeframe and completed on time for site shutdown timeline Show less
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Senior Manufacturing Engineer
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Oct 2018 - Jan 2020
Invuity, now a part of Stryker Partner with contract manufacturers to troubleshoot and resolve costly scrap or quality issues by stabilizing yields to >95% or >99% and prevent future monthly scraps costs of $15K to $30K
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Manufacturing Engineer
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Nov 2017 - Oct 2018
Enact product improvements for manufacturability that reduced part cost by 44% and streamline manufacturing processes to reduce cycle time by 50% o Utilize quality plans, design verification / functional testing, and process validations (IQ, OQ, PQ) as appropriate in accordance with the local QMS and ISO 13485 and 21 CFR Part 820 standards Enact product improvements for manufacturability that reduced part cost by 44% and streamline manufacturing processes to reduce cycle time by 50% o Utilize quality plans, design verification / functional testing, and process validations (IQ, OQ, PQ) as appropriate in accordance with the local QMS and ISO 13485 and 21 CFR Part 820 standards
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Abbott
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United States
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Hospitals and Health Care
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700 & Above Employee
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Manufacturing Engineer
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Jan 2017 - Nov 2017
Abbott Mechanical Circulatory Support Division St. Jude Medical is now a part of Abbott Design and develop manufacturing processes o Design manufacturing fixtures and create drawings while utilizing DFM and GD&T principles o Develop manufacturing process by proactively driving quality, manufacturability, and yield improvements o Troubleshoot manufacturing processes and equipment while working within a team to complete CAPAs o Create and update manufacturing and quality inspection procedures and vendor instructions o Interface with suppliers/vendors for part quality and inspection alignment o Train operators on new and updated processes o Assist in developing packaging processes and reviewing transit and shelf-life test reports Develop and execute process validation protocols and reports (IQ, OQ, PQ, PPQ/Line Validation, MVP, MVR, Supplier Process Validations) o Includes other activities such as: Process Characterization studies, DOE studies, and risk assessment (pFMEA) while aligning with Design Input Requirements (DIR), dFMEA, and Patient Risk Assessments (PRA) Work with cross-functional teams (R&D, Quality, Manufacturing Engineering, Production, Supply Chain, and Regulatory) to ensure that design, quality, manufacturability, yield, production capacity and regulatory requirements are met. Show less
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St. Jude Medical
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Manufacturing Engineer
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Oct 2015 - Dec 2016
St. Jude Medical Mechanical Circulatory Support Division Thoratec is now a part of St. Jude Medical St. Jude Medical Mechanical Circulatory Support Division Thoratec is now a part of St. Jude Medical
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Thoratec, now a part of St. Jude Medical
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Medical Equipment Manufacturing
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100 - 200 Employee
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Manufacturing Engineer
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Oct 2011 - Oct 2015
Develop manufacturing process validation procedures (IQ, OQ, PQ, MVP, MVR), process characterization studies, DOE studies, statistical process controls, pFMEAs, and manufacturing processes (fixture design and drawings, fabrication documentation, traveler documentation, quality assurance procedure documentation) for outside and inside cleanroom environments. Perform tolerance analyses, process capability analyses, and tolerance limit analyses. Follow SOPs. Follow change order procedures for implementing changes into document control. Work with cross functional teams (R&D, Manufacturing Engineering, Production, Quality, Supply Chain, and Regulatory). Improving manufacturing processes to reduce cost, lead time, and/or quality. Utilize design for manufacturability and GD&T principles. Show less
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Articulinx
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Cupertino, CA
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Engineering Consultant
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Nov 2010 - Nov 2011
Designed components for product verification testing Responsible for product verification testing Developed operating procedures for verification testing Designed components for product verification testing Responsible for product verification testing Developed operating procedures for verification testing
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Kinematic Automation (now part of Ascential Medical & Life Sciences)
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United States
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Automation Machinery Manufacturing
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1 - 100 Employee
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Engineering Intern
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May 2009 - Dec 2009
Created technical part and assembly drawings for parts Redesigned parts for customized products Responsible for numerous small projects Designed air dispersion module Designed parts for a prototype test station and later assembled it Conducted conceptual engineering testing and reported the results Designed pneumatic slide testing platform and created testing procedures Developed internal project proposal template document Created technical part and assembly drawings for parts Redesigned parts for customized products Responsible for numerous small projects Designed air dispersion module Designed parts for a prototype test station and later assembled it Conducted conceptual engineering testing and reported the results Designed pneumatic slide testing platform and created testing procedures Developed internal project proposal template document
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Haeger
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United States
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Mechanical Or Industrial Engineering
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1 - 100 Employee
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Engineering Intern
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Jan 2008 - May 2008
Tested the stiffness of plastic springs for vibrating bowl Experimented with different arrangements of plastic springs to increase effectiveness of the vibrating bowl Redesigned and built a tooling test station with touch screen interface to assist the quality control testing Tested the stiffness of plastic springs for vibrating bowl Experimented with different arrangements of plastic springs to increase effectiveness of the vibrating bowl Redesigned and built a tooling test station with touch screen interface to assist the quality control testing
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Education
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University of the Pacific
BS, Mechanical Engineering