Staff Supplier Engineer Resume Cesar Shaw Staff Supplier Engineer (510) 555-6724 cesar.shaw@example.com linkedin.com/example/cesarshaw Fremont, CA 94538 STRENGTHS Supplier partnership Built clear technical expectations with external suppliers, and difficult process conversations became practical improvement plans. Validation leadership Connected characterization, inspection, and production evidence so teams could move forward with greater confidence. Root cause focus Stayed with recurring defects until data exposed a useful cause, giving corrective actions lasting value. Cross functional delivery Worked across engineering, quality, purchasing, and supply chain when a decision needed both speed and control. Mentoring Shared validation and regulatory judgment with engineers, often becoming a quiet resource during difficult reviews. SKILLS Supplier engineering Manufacturing engineering Medical devices Robotics Mechatronics Plastics Process development Production validation GD&T DFM/A SPC Capability analysis Root cause analysis Supplier qualification Risk management LANGUAGES English Native 40 Spanish Proficient 30 MY CAREER 9.7 Years Staff Supplier Engineer at NovaMotion Medical Systems (3.7 Years) Senior Supplier Quality Engineer at Redwood Surgical Technologies (2.7 Years) Manufacturing Engineer at Pacific Mechatronics Health (1.8 Years) Supplier Manufacturing Engineer at BayTech Medical Components (1.6 Years) SUMMARY Staff level supplier and manufacturing engineer with 10 years supporting regulated medical devices , robotic systems, mechatronic assemblies, and plastic components. Leads supplier process development from design transfer through tooling, characterization, production validation, scale up, and sustaining production. Partners across R&D, Manufacturing Engineering, Quality, Purchasing, Supply Chain, Marketing, and Finance to turn design requirements into capable, controlled manufacturing processes. Applies GD&T, DFM/A, SPC, capability analysis, FMEAs, root cause analysis , CAPA, Six Sigma, Lean, risk management, and inspection strategy across supplier programs. Uses 21 CFR Part 820 and ISO 13485 requirements to guide validation evidence, supplier controls, and change decisions. Mentors engineers, resolves process issues with data, and supports reliable product performance, quality, cost, and production growth. EXPERIENCE Staff Supplier Engineer NovaMotion Medical Systems January 2023 - Present Fremont, CA Leads supplier engineering for plastic components and precision sub assemblies in robotic medical devices. Owns technical delivery from design transfer through validated production, supports scale up, guides engineers, and aligns supplier decisions with quality, cost, risk, and production goals. Led plastic component validation using GD&T and SPC, supporting reliable robotic device production. Directed tooling characterization and inspections, resolving process window constraints before program milestones. Drove supplier CAPA investigations using FMEAs, capability studies, and corrective action evidence. Applied DFM/A reviews to balance product performance, manufacturing stability, quality, and component cost. Mentored engineers on Six Sigma , Lean, ISO 13485 , and supplier technical governance. Senior Supplier Quality Engineer Redwood Surgical Technologies April 2020 - December 2022 Sunnyvale, CA Managed supplier qualification and improvement for molded plastics, machined components, and electromechanical surgical assemblies. Coordinated validation, supplier selection , design clarification, audit support, and sustaining controls across regulated production programs. Qualified molded plastic suppliers through capability reviews, tooling assessment, and production readiness evidence. Planned process validations using risk analysis, SPC , drawings, GD&T, and measurement evidence. Resolved recurring supplier nonconformances through root cause analysis and CAPA effectiveness reviews. Clarified design requirements with engineering before specifications entered supplier production controls. Supported ISO 13485 audits, 21 CFR Part 820 controls, and manufacturing change reviews. Manufacturing Engineer Pacific Mechatronics Health June 2018 - March 2020 San Mateo, CA Developed electromechanical and plastic sub assembly processes for minimally invasive medical equipment. Supported prototype transition, controlled production, validation planning, supplier manufacturability, risk controls, and cross functional process changes. Developed plastic sub assembly processes, moving prototype methods into controlled medical production. Created characterization protocols covering critical parameters, equipment settings, inspections , and repeatability. Applied drawings and GD&T to fixture decisions, inspection plans, and supplier manufacturability reviews. Prioritized quality controls through FMEAs, capability analysis , SPC, and risk management . Coordinated process changes with Quality, R&D , Purchasing, and Supply Chain teams. Supplier Manufacturing Engineer BayTech Medical Components October 2016 - May 2018 Hayward, CA Supported suppliers producing injection molded plastics and mechanical components for regulated medical device assemblies. Reviewed drawings, tooling, inspections, validation evidence, corrective actions, Lean improvements, and compliance documentation. Reviewed drawings, GD&T , tooling concepts, and inspection plans before supplier qualification release. Executed process studies using statistical methods, measurement data, and documented acceptance criteria. Investigated supplier defects with structured root cause methods and verified corrective action effectiveness. Applied Lean and Six Sigma tools to improve process stability and inspection discipline. Maintained supplier qualification , manufacturing change, ISO 13485, and 21 CFR Part 820 records. PROJECTS Robotic Plastic Component Scale Up 2024 A narrow process window threatened production timing. Led supplier characterization, capability analysis, tooling review, and inspection planning that supported validated scale up for robotic medical device components. Electromechanical Assembly Validation 2019 A prototype assembly needed repeatable production controls. Built characterization protocols, reviewed tolerances, aligned supplier evidence, and supported controlled manufacturing for minimally invasive medical equipment. LEADERSHIP & AWARDS Six Sigma Green Belt recognition, 2019 Staff level supplier engineering appointment, 2023 Technical Mentor, Medical Device Supplier Engineering Peer Forum, 2023 to Present EDUCATION Bachelor's Degree in Mechanical Engineering San Jose State University GPA: 3.5 2016 San Jose, CA Coursework: Engineering design, manufacturing processes, statistics, quality systems CERTIFICATIONS Six Sigma Green Belt 2019 ISO 13485 Quality Systems Training 2020 TECHNICAL SKILLS Quality Standards: 21 CFR Part 820, ISO 13485, supplier controls Statistical Methods: SPC, capability analysis, measurement systems Risk Tools: FMEA, risk management, control plans Manufacturing Methods: Lean, Six Sigma, process characterization Design Engineering: GD&T, DFM/A, engineering drawings Supplier Management: Qualification, selection, improvement Plastics Manufacturing: Injection molding, tooling, plastic components Validation Activities: Process validation, production validation, scale up Quality Investigation: Root cause analysis, CAPA, corrective actions Inspection Systems: Dimensional inspection, inspection plans, measurement evidence Medical Robotics: Robotic devices, mechatronics, electromechanical assemblies SKILLS Supplier engineering Manufacturing engineering Medical devices Robotics Mechatronics Plastics Process development Production validation GD&T DFM/A SPC Capability analysis Root cause analysis Supplier qualification Risk management PROFESSIONAL AFFILIATIONS Medical Device Supplier Engineering Peer Forum Technical Mentor, supplier engineering peer community LANGUAGES English (Native) Spanish (Proficient) ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. REFERENCES AVAILABLE ON REQUEST
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