Manufacturing Engineer Medical Devices

Overview: Innovative and confident professional with over 15+ years of hands-on, broad engineering

expertise across various functions and projects in Automotive & Medical Devices, spanning from initial concepts to scale-up to large-scale production. With a natural manufacturing engineering talent, I consistently exhibit a proactive goal driven attitude and a versatile mindset; I am always up for a challenge. I have played a pivotal role in driving the achievements of private companies, being a critical asset participating from their initial startup phases to eventual acquisition. Soft Skills:

• Self-Starter & Self-Motivated

• Flexible & Adaptable

• Sense of Urgency & Fast Paced

• Leadership & Mentorship

• Communication, Effective & Concise

• Organization & Time Management

• Project Management

• Meetings Lead & Ownership

• ISO 9001, 13485, 21 CFR 820

Technical Skills:

• Process & System Engineering,

Optimization & Control

• Root Cause & Failure Analysis:

Equipment, Systems, SW

Mechanical, Electromechanical,

• Problem Solving; DMAIC, 5-

Why’s, Fishbone, 8D, Ishikawa

• Lean Manufacturing; Six Sigma,

5S, KAIZEN

• Quality Control - SPC, Gauge

R&R, DOE, Poke-Yoke

• SolidWorks, AutoCAD, DFM

• Fixture & Equipment design,

modification, improvement

• Machining (hands-on), Additive

Manufacturing, Composites, Molding;

Injection, Extrusion, Thermoforming

• Engineering Drawings, GD&T,

mechanical, electrical schematics,

Optical diagrams

• Material Science; capabilities,

processing, implementation

• Validation (V&V, AQPQ, PPQ,

IQ, OQ, PQ)

• Technical Documentation

(ECO, DCO, BOM, MPI, LHR,

NCR, CAPA, PFMEA, etc.)

• Data Analysis (MiniTab, JMP)

Mfg Data, Yield data, Test

data (Tableau, SQL)

• MS Office, Mac OS, Linux,

ERP, PLM, SAP, TeamCenter

Experience:

Intuity Medical, January 2024 – June 2024

Sr Automation Manufacturing Engineer for Blood Glucose Monitoring Device

• Trained and certified to World Class Manufacturing (WCM) by Engage Performance Ltd. Which led to successfully resolving historic ongoing issues that were hindering the improvement targets.

• Effectively utilize lean manufacturing tools & WCM techniques to rapidly ramp-up production volumes by ~24% in unprecedented times

• Author/improve manufacturing instructions, travelers, Bill of Materials, Automated equipment debug & root cause decision trees

• Define automation needs not previously identified, set requirement specifications and manage over three automation programs and project schedules.

• Improved machine stability (3 of 5); including throughput monitoring (time-studies), identifying yield-loss, root causing and defining & implementing solutions promptly to minimize downtime.

• Troubleshoot and root cause; mechanical, electromechanical, PCBA components using Software, Oscilloscopes, Spectrum analyzers, Multimeters, etc. JAIME VASQUEZ

Manufacturing Engineer

Email: *******.*****.*****@*****.***

Phone: 650-***-****

LinkedIn: linkedin.com/in/jaime-vasquez-me

• Installation of sensors, improved controls, and reject recognition equipment in collaboration with Controls Engineering for PLC programming.

• Author & execute over five validations for new and existing equipment and processes.

• Led and executed engineering builds and testing to improve design and quality efforts.

• Develop timelines and provide direct oversight and management of automation suppliers as well as driving the implementation and validation of manufacturing lines. Aeva Inc., April 2018 – January 2024

Manufacturing Engineer/TPM for a 4D LiDAR Sensor for Autonomous Applications

• Laser & Optics-electromechanical sensor; Manufacturing line end-to-end ownership; assembly and test fixture development, line set-up & bring-up, duplication and validation.

• Author of +90% of the manufacturing documentation; Process flows, MPIs, LHRs, IQC/OQC, etc.

• Troubleshoot and root cause; electronic, PCBA, optical components using Software debug tools, Spectrum Analyzers, Oscilloscopes, Multimeter, etc.

• Work with CMs, vendors and suppliers to select new fabrication methods, develop and coordinate new and increased production initiatives, while driving COGS down.

• Perform failure analysis, root cause investigations and drive cross-functional teams to close out issues and implement corrective actions all while minimizing impact to product throughput.

• Serve as technical liaison between hardware, software, quality assurance, vendor and supplier personnel to resolve technical and quality issues.

• Determine most effective approaches to new projects by analyzing design drawings and prototypes, providing DFM feedback to HW, ME, OE teams on a continuous basis.

• Perform fixture design, manufacturing engineering and other functions to reduce time required to bring product to market.

• Track and report production goals, accomplishments and deficiencies to upper-management and stakeholders on-ongoing basis.

Earlens Corp., Jan 2017 – April 2018

R&D Engineer for Revolutionary Hearing Aid

• Custom Products engineering focused in rapidly developing and implementing custom solutions.

• Integrated cutting-edge technologies into the current hearing-aid design yielding a ~20% increase in in-ear retention.

• Invented, designed and built R&D prototypes for bench- top and clinical evaluation, working closely with Lead Physicians to quickly develop and evolve concepts, typically within 24 hrs.

• Tested new designs, gathering and analyzing data to make necessary design refinements to maximize concept potential.

• NPI - Creation and bring-up of new products manufacturing processes; implementing solutions for critical component assembly where current processes yielded inconsistent results, including fixture development and procedure clarification.

• Installation and set-up of new equipment, including IQ/OQ/PQ validation authoring & execution.

• Evaluated current manufacturing processes, implementing lean-manufacturing principals in workflow, quality and waste reduction, resulting in ~15-20% yield increase

• Training of manufacturing personnel on new processes and techniques.

• Regular team advancements reporting to upper management, stakeholders and physicians. PneumRx Inc., July 2005 – April 2018

Various Roles, leading up to Manufacturing Engineer for Implant & Delivery System for treating COPD. I. Manufacturing Engineer 2015 – 2018

• Key contributor to Manufacturing for increasing and maintaining increased production volumes and reducing manufacturing costs providing ~15% production cost decrease

• Collected and analyzed production data to determine process capabilities (Cpk, Ppk) in order to improve quality and improve volume throughput.

• Developed and executed process validations, equipment validations, test method validations, vendor qualifications and material qualifications

• Developed action plans to aid in meeting defined objectives and streamlining existing processes.

• Executed engineering reports summarizing test results/data analysis and provide data driven justification for process or design changes.

• Initiated and executed Non-Conformance reports and Corrective Action Plans as necessary to further improve processes and address quality issues. II. Associate Manufacturing Engineer, 2012 – 2015

• Develop and execute process validations and equipment validations protocol, e.g. IQ/OQ/PQ’s.

• Responsible for completing NCR’s and CAPA’s - investigation of root cause, corrective action and preventative action reports.

• Design, development, and implementation of fixtures, tools and process aids to reduce production times and waste.

• Design and improve process flow and production line setup.

• Create/develop and improve manufacturing instructions and LHRs.

• Address and improve yield issues.

• Initiate and complete design changes and updates through DCO/ECO process. Previous Roles at PneumRx

III. Senior R&D Technician, 2009 – 2012 – Significant contributions to launch product to clinical trials IV. R&D Technician, 2006 – 2009 – Major involvement in GLP studies, Product efficacy characterization V. Production Technician, 2005 – 2006 – Aided in development of first prototypes and design refinement Education:

Bachelor of Science – Mechanical Engineering, January 2008 – June 2011 San Jose State University – San Jose, CA

• Relevant Coursework Completed: Mechanical Engineering Technology & Production Technology

• Member of Engineers Without Borders (EWB)

Associate of Science – Engineering Technology, January 2006 – August 2008 Ohlone College – Fremont, CA

• Lower division Courses completed for transfer to UC or CSU.

• Awarded Outstanding Student Award in Engineering Technology Accomplishments:

Inventor and co-inventor of over 20 granted patents and many applications pending by the USPTO and other Country's Patent Offices.

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