Cre, Cqe, Cmq/Oe, Cssbb, Cmda, Pm

Oscar Solis (CRE, CMDA, CQE, CMQ/OE, CSSBB, PM)

San Diego, CA 503-***-**** ******@*******.*** https://www.linkedin.com/in/oscar-solis-1509a395/

Strategic and results driven engineering leader with progressive experience managing and implementing global quality systems / NPI / Sustaining / OPEX / CAPEX projects to completion through efficient management of resources and constructive team building.

CORE COMPETENCIES

Process Development & Improvement Project Management Change Agent Analytical Thinking Effective Communication Strategic Leader Goal-Driven Effective Team Builder Prioritization / Time Management Coach / Mentor Systems Thinking Emotional Intelligence

PROFESSIONAL EXPERIENCE

INOVIO, San Diego, CA June 2020 – October 2023

Senior Manager, Product and Process Quality

Champion, mentor and coach in the implementation of best manufacturing practices and design for manufacturing of new products and processes.

Partnered with suppliers to develop sustainable processes capable of consistently producing quality products, through advanced product quality planning.

Led process qualifications (IQOQPQ), method validations, and product V&V activities,

Mentored and coached cross-functional teams in best manufacturing practices, as acting design quality SME and process quality assurance SME.

Implemented and championed design quality review process.

Developed internal and external (suppliers) inspection processes to comply with increasing demand and ensure adequacy and accuracy of detection methods.

Achievements:

Successful implementation and validation of automated assembly equipment for mass production of commercial medical devices.

Successful qualification of 30+ supplier manufacturing processes for custom mechanical components.

Increased supplier quality performance by implementing and leading advance quality planning and quality design review.

Illumina, San Diego, CA August 2018 – February 2020

Staff Quality Engineer

Managed and drove implementation of global quality system projects, including championing Six Sigma approach in process development by coaching and mentoring staff.

Drove best practices in Project Management per PMBOK, including the standardization for Quality systems Project Management.

Led Change Management with global sites and cross-functional stakeholders by creating partnerships with each site’s leadership (Upper Management) to enable and empower the team.

Secured and managed resources, budgeting, and quality for OPEX and Quality System projects, which often meant socializing the initiative and negotiating with cross-functional leadership.

Coached and Mentored project stakeholders and site project leaders (APAC, EMEA & NAM) on six sigma methodology and industry standard practices to ensure a successful project execution.

Championed project feasibility and impact assessments for new project requests, engaging directly with internal customers and associated stakeholders.

Achievements:

SAP - RMA Process automation

SAP - Non-conforming / suspect product containment

JAE, Tualatin, OR March 2015 – February 2018

Quality Engineer 3

Managed the final assembly process quality assurance of connectors for the automotive industry, driving Six Sigma Continual Improvement Projects and serving as a coach and mentor to staff.

Managed CAPEX and OPEX projects for final assembly, which included championing six sigma by mentoring and coaching team members in best practices.

Led APQP for NPI and Sustaining projects, partnering with cross-functional stakeholders to promote continual process improvement and standardization.

Championed SPC process implementation and maintenance, to ensure compliance to standards and alignment with quality plan.

Managed offsite inspection (JAE Tijuana) process, including compliance, documentation and training.

Managed final assembly customer complaint CAPAs and customer interface, through 8D process.

Audited quality system to comply with TS16949, ISO14001 and VDA 6.3.

Achievements:

NPI offsite inspection process implementation, including achieving compliance with TS16949 and VDA 6.1.

APQP process standardization in alignment with customer and ISO/TS/VDA requirements

EATON Aerospace, Tijuana, B.C. Mexico March 2013 – February 2014

Senior Product Engineer

Oversaw Engineering Change Management and Product Sustaining of switches and valves for the aerospace industry.

Managed electromechanical business unit site engineering changes through ECO process.

Mentored and coached staff members on six sigma projects and failure analysis / investigation.

Led design changes, including mechanical drafting, design validation and verification, and implementation process.

Supported OPEX projects by partnering with quality, purchasing and manufacturing, and providing them with guidance in change management

Achievements:

Implemented first design changes and design change process in-site.

Led over 40 OPEX projects which resulted in better production yield, scrap reduction, and end customer problem resolution.

Implemented deviation request process to ensure better response time from parent site, and timely corrective action closure.

CST - Kavlico Corporation, Tijuana, B.C. Mexico January 2011 – March 2013

Product Engineer

Led sustaining engineering of clean room processes (thick film printing, wire bonding, soldering, SMT).

Led design implementation for new product Introduction, including drafting, documentation of process and design, and validation / verification of change and product.

Led raw material selection and validation projects, which included supplier qualification, product and process validation.

Supported OPEX projects by partnering with quality, purchasing and manufacturing, and leading change management effort and coaching the team through the process.

Designed poka yoke fixtures and product features, and conducted various product design improvements.

Generated and revised drawings, procedures, engineering reports, work instructions, flow charts, routers and other engineering documentation.

Achievements:

Led clean rooms raw material investigation (process validation and materials analysis) to increase process capability, which resulted in a 1.2M dollar cost avoidance.

Led solder improvement project to increase reliability and process capability, resulting in a 20% yield increase rate and risk mitigation.

Led new thick film conductor paste implementation, to improve product reliability and manufacturability. This resulted in a 30% cost reduction on the conductor paste approximately, and a 5-10% reduction to scrap.

Carefusion, Tijuana, B.C. Mexico December 2009 – November 2010

Product Engineer

Managed NPI and sustaining engineering projects of intravenous infusion technology.

Led over 30 custom product introduction projects (Intravenous infusion sets design) from concept to delivery to customer.

Generated and revised NPI process work instructions for continual improvement and compliance with ISO13485 and other requirements.

Supported continual improvement projects with product and quality system guidance.

Led re-branding projects for Cardinal Health's transition to Carefusion.

Achievements:

Reduced project cycle time down to 35% of standard project time cycle by identifying critical path and optimizing task coordination and communication. This was achieved by partnering with cross-functional team members and working on ways to improve communication and deployment process efficiency

Increased on time project deliverables from 30% achieved in 2009, to 70% on 2010, by improving and documenting a more efficient methodology.

Developed and implemented an online library to standardize engineering drawing and artwork content.

Developed and implemented product engineering database for device management, and to record change history and lessons learned.

HST Aerospace, Tijuana, B.C. Mexico July 2007 – May 2009

Manufacturing Engineer

Managed NPI, sustaining, design and implementation of thermal-acoustic insulation technology for the aerospace industry.

Managed thermal–acoustic insulation blankets design projects from design to process implementation and validation.

Led quality projects to improve inspection accuracy and efficiency, where methods and training were where redefined.

Developed new installation drawings, cut files and assembly drawings in AutoCAD.

Developed assembly and validation fixtures for new and existing designs in Solid Works and AutoCAD.

Conducted quality and production personnel training on inspection criteria for new products, which included providing basic math classes to the production and quality personnel (extracurricular) to ensure their success.

Conducted Internal audits in accordance to ISO 9001/AS9100.

Achievements:

Improved first time yield rate of new designs by up to 30%

Improved yield rate of legacy designs by up to 20%.

EDUCATION

Bachelor of Science in Electromechanical Engineering - Instituto Tecnologico de Tijuana, Tijuana, B.C. Mexico

TRAINING & PROFESSIONAL DEVELOPMENT

Omnex - ISO14001:2015 EMS Auditor (2017)

AIAG IATF 16949:2016 Supplier Auditor Certification (2017)

Project Management at PSU (2016)

Omnex - Lean Six Sigma Boot Camp (2016)

International Institute of GD&T – Precision GD&T – Intermediate Principles (2016)

Omnex – Core Tools Training (2015)

Karrass – Negotiating effectively within your own organization (2015)

Omnex – QMS Auditor for the Automotive Industry (2015)

Shainin Apprentice (2012) – Pending certification

GD&T and Tolerance Analysis (2012)

Professional Project Administration (2010)

Solidworks Essentials (2009)

CERTIFICATIONS

Certified Medical Device Auditor – ASQ (2024)

Certified Reliability Engineer – ASQ (2024)

Certified Six Sigma Black Belt – ASQ (2017)

Certified Manager of Quality/Organizational Excellence – ASQ (2016)

Certified Quality Engineer - ASQ (2015)

Certified IPC Trainer (2011)

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