Michael Espino
Sunnyvale,CA
Summary
Dynamic Quality Engineer with a proven track record of enhancing product quality and manufacturing efficiency through expert application of Lean Manufacturing and Root Cause Analysis. Contributed to multiple successful product launches and quality improvement initiatives, demonstrating exceptional collaboration and problem-solving skills. Achieved significant process optimizations, ensuring compliance with FDA and ISO 13485:2016 standards.
Overview
21
21
years of professional experience
Work History
NPI Quality Engineer
Stryker Endoscopy
01.2023 - Current
- Ensured successful product launches through effective team collaboration.
- Collaborated with suppliers to secure on-time delivery of materials and components.
- Work with Design Engineers to guarantee manufacturability of new products.
- Collaborated with Quality Engineering to define inspection standards.
- Implemented efficient manufacturing processes like MAPs, QIPs, and DHRs for new products.
- Performed PFMEA assessments to mitigate risks in existing production operations.
- Verified conformance with established regulatory and quality protocols.
- Work closely with Quality Assurance teams to verify product reliability.
- Facilitated PPAP process for components to verify supplier quality compliance.
- Created process control plans for upcoming product procedures.
- Contributed to Design Reviews by offering constructive feedback on product designs.
- Coordinated with cross-functional teams during design verification testing activities.
- Conducted design validation builds for new products and recommended design adjustments.
- Assisted in the development of new products from concept through design validation stages.
Senior Quality Specialist
Alexza Ferrer
01.2022 - 01.2023
- Manage work priorities to ensure timely review and release of drug products.
- Maintained, developed and implemented documentation for manufacturing processes.
- Reviewed and approved deviations, investigations, CAPA, and change controls for Alexza products.
- Assess deviations from procedures and analyze their impact on drug products.
- Provide quality guidance on manufacturing and laboratory investigations and problem-solving activities
- Provided signatory authorization of final product disposition for clinical and commercial use
- Ensured uninterrupted drug availability for clinical product trials.
- Participate in internal and external audits
- Evaluated test methodologies and documentation.
- Fostered collaborative relationships with cross-functional teams including Operations, Product Development, and Quality Control.
- Analyzed situations or data involving a range of factors to address complex challenges.
Associate Quality Engineer/Quality Engineering Technician
Stryker Endoscopy
San Jose
01.2010 - 10.2022
- Elevated production quality metrics by leveraging trends in yield data.
- Reviewed and revised BOMs for PCBAs and components, ensuring EOL issues were addressed via SCR processes.
- Managed CAPA initiatives by identifying root causes and implementing corrective measures for device issues.
- Develop, update and manage production MAP's QIP's, DHR's, and packaging procedures to ensure compliance with regulatory standards.
- Facilitated training sessions for production associates on updated procedures.
- Facilitated completion by implementing effective corrective actions.
- Monitored trends in nonconforming materials for process improvements.
- Oversee approval processes for production parts, maintaining thorough documentation.
- Supported Manufacturing Engineer by addressing and solving day-to-day production problems.
- Collaborated with cross-functional teams for development of new products and updates to meet customer requirements.
Lean Manufacturing Technician
Stryker Endoscopy
01.2008 - 01.2009
- Executed Lean Manufacturing methodologies to drive productivity gains and operational cost reductions.
- Implemented tools like Standardized work, One Piece Flow and 5S to enhance labor efficiency across product lines
- Led initiatives using A-3 problem solving techniques and TIMWOOD principle to streamline processes
Sr. Manufacturing Technician
Stryker Endoscopy
01.2006 - 01.2007
- Ensured successful implementation and oversight of ESD program objectives.
- Integrated ANSI/ESD 20.20 standards into Standard Operating Procedures.
- Conducted regular ESD audits internally and at supplier locations
- Partnered with engineering teams to confirm the reliability of product software updates and developments.
- Developed innovative fixtures that enhanced testing of product reliability.
Quality Technician
Stryker Endoscopy
01.2004 - 01.2005
- Identified and analyzed quality issues through systematic troubleshooting based on customer complaints.
- Collaborated with Quality Engineer to analyze failure trend metrics.
- Performed analysis on failures to resolve issues highlighted by customer complaints.
- Identified enhancements to improve product quality.
Education
Bachelor's Degree - Technical Management
DeVry University
Associate of Applied Science - Electronics
DeVry University
Associate of General Studies -
Phoenix College
Skills
- Lean Manufacturing
- SCR
- Root Cause Analysis
- Process Improvement
- Manufacturing Process Engineering
- Implementation of Test Protocols
- Development of Process Control Plans
- Failure Mode Analysis
- Process Failure Mode Effects Analysis
- FDA Regulatory Understanding
- TUV Compliance Knowledge
- BSI Standards Familiarity
- Nonconformance Management
- Corrective Action Process
- ISO 13485:2016 Standards Knowledge
- Expertise in Oracle Agile PLM Solutions
- Production Part Approval Processes
- Quality Improvement Initiatives
- IQ/OQ/PQ
- Design Verification
- Design Validation
- Medical Device Management
- Pharmaceutical Knowledge
- Proficient in Microsoft Office
- Management of Document Changes
- Materials Review Board
Timeline
NPI Quality Engineer
Stryker Endoscopy
01.2023 - Current
Senior Quality Specialist
Alexza Ferrer
01.2022 - 01.2023
Associate Quality Engineer/Quality Engineering Technician
Stryker Endoscopy
01.2010 - 10.2022
Lean Manufacturing Technician
Stryker Endoscopy
01.2008 - 01.2009
Sr. Manufacturing Technician
Stryker Endoscopy
01.2006 - 01.2007
Quality Technician
Stryker Endoscopy
01.2004 - 01.2005
Bachelor's Degree - Technical Management
DeVry University
Associate of Applied Science - Electronics
DeVry University
Associate of General Studies -
Phoenix College
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