Staff OT Manufacturing Engineer, Shockwave Resume Weston Guerra Staff OT Manufacturing Engineer, Shockwave (408) 555-6742 weston.guerra@example.com linkedin.com/example/westonguerra San Jose, CA 95126 STRENGTHS Validation leadership Built traceable IQ, OQ, and PQ records for system releases. Quality partners gained clearer evidence and faster review. OT security judgment Applied segmentation, VLANs, firewalls, and access controls during remote support work. Teams trusted practical risk decisions. Controls troubleshooting Followed faults from PLC logic through HMI behavior and communications. Production teams found issues easier to explain. Vendor coordination Turned scope reviews, FAT, and SAT findings into visible actions. Integrators had fewer surprises during commissioning. Process improvement Used DMAIC, SPC, Cpk, and OEE data to focus improvement work. Operators saw useful changes, not extra paperwork. SKILLS Operational Technology Manufacturing Engineering PLC and PAC Controls Rockwell Controls Siemens Controls HMI and SCADA IEC 61131 3 MES Integration Industrial Networking OT Cybersecurity IQ OQ PQ Validation pFMEA and DMAIC SPC and Cpk Vendor Management Technical Communication LANGUAGES English Native 40 Spanish Proficient 30 MY CAREER 13.6 Years Staff OT Manufacturing Engineer at HelixPoint Medical Devices (3.7 Years) Senior Controls and Automation Engineer at NovaCell Therapeutics (2.4 Years) Controls Engineer at Precision Cardio Systems (3 Years) Manufacturing Automation Engineer at BayTech Life Sciences Automation (2.9 Years) Junior Controls Engineer at Vector Process Controls (1.6 Years) SUMMARY Staff level OT manufacturing engineer with 12 years supporting regulated medical device and life sciences production. Leads controls, automation , validation, cybersecurity, and OT IT integration from requirements through commissioning, ramp, and sustained operations. Hands on work spans Rockwell, Siemens, FactoryTalk, Ignition, MES interfaces, ISA 95, OSIsoft PI, industrial networks, and secure remote access . Builds practical validation plans, protocols, trace matrices, and controlled records for IQ, OQ, and PQ. Uses pFMEA, DMAIC, SPC, Cpk, OEE, and Minitab analysis to improve reliability and production insight. Partners with Quality, IT, Production, R&D, Supply Chain, and Regulatory teams, while guiding integrators, vendors, and junior engineers. Brings steady judgment to production issues and can support safe, compliant OT delivery for complex manufacturing operations. EXPERIENCE Staff OT Manufacturing Engineer HelixPoint Medical Devices January 2023 - Present San Jose, CA Owns regulated OT architecture, controls delivery, validation, cybersecurity, vendor governance, and production sustainment across medical device operations. Guides cross functional decisions from requirements through release and mentors controls engineers. Architected Rockwell controls and Ignition interfaces for production expansion, improving commissioning readiness across manufacturing cells. Created IQ, OQ, and PQ trace matrices for MES releases, giving Quality clear evidence for approval. Segmented OT networks with VLANs and firewalls, reducing exposure during secure remote maintenance activities. Used PI historian data with OEE reviews, helping Production isolate recurring downtime patterns and corrective actions. Directed integrator reviews, FAT, SAT, and ramp support, keeping technical decisions visible across stakeholder teams Senior Controls and Automation Engineer NovaCell Therapeutics July 2020 - December 2022 South San Francisco, CA Led Siemens controls, GMP automation, MES integration, validation, and process capability work for life sciences production. Coordinated vendors and internal partners through factory testing, site acceptance, release, and support. Programmed Siemens PLC sequences using IEC 61131 3 methods, supporting repeatable GMP equipment operation. Mapped ISA 95 MES handshakes and recipes, clarifying batch data exchange during system acceptance testing. Built FAT and SAT protocols with controlled records, helping validation teams close findings before production release. Applied SPC, Cpk , and Minitab analysis to process data, guiding practical adjustments for stable output. Led vendor technical reviews and commissioning workshops, giving operators clearer training and support materials Controls Engineer Precision Cardio Systems June 2017 - June 2020 Sunnyvale, CA Delivered medical device controls, HMI applications, MES handshakes, risk assessments, and validated commissioning. Supported production teams with troubleshooting, corrective action, documentation, and process monitoring. Configured FactoryTalk HMI screens for assembly equipment, helping operators identify alarms and recover production faster. Performed pFMEA reviews for automated fixtures, turning failure modes into testable controls and documented actions. Applied DMAIC root cause analysis to communication faults, restoring dependable equipment behavior during commissioning . Verified I O lists , wiring diagrams, and control narratives , giving technicians reliable references during startup. Coordinated Quality and Production reviews for validated changes, preserving traceability through release and sustainment Manufacturing Automation Engineer BayTech Life Sciences Automation June 2014 - May 2017 Fremont, CA Supported regulated automation delivery, PLC and HMI change control, qualification, downtime analysis, and vendor coordination. Helped manufacturing teams move equipment from technical review through commissioning and reliable daily operation. Delivered PLC and HMI change packages for regulated equipment, supporting controlled commissioning and qualification. Analyzed downtime records with production leads, prioritizing practical fixes for recurring automation interruptions. Coordinated vendor scope and technical reviews, keeping drawings, specifications, and acceptance needs aligned. Prepared commissioning records and operator procedures, helping teams adopt new equipment with fewer startup questions. Supported risk assessments and corrective actions, linking equipment changes with quality and safety expectations Junior Controls Engineer Vector Process Controls October 2012 - May 2014 Santa Clara, CA Developed early controls engineering experience through Rockwell programming, HMI configuration, I O verification, FAT execution, and electrical documentation. Worked with senior engineers and technicians on equipment delivery and troubleshooting. Built Rockwell Ladder Logic updates under senior review, supporting dependable machine sequences during factory testing. Configured HMI tags and alarm screens, giving technicians clearer feedback during equipment troubleshooting. Verified I O points against electrical drawings, catching wiring discrepancies before FAT execution. Recorded FAT results and open issues, helping project teams track fixes through customer acceptance. Assisted controls troubleshooting at startup, building practical knowledge of safe commissioning and production support PROJECTS Secure OT Integration Program 2026 Strong results start with clear control. Delivered a cross site OT integration framework connecting PLC, HMI, MES, historian, and secure network services for regulated production, with validation evidence and sustainment practices. Validated Production Data Flow 2025 Good engineering creates room for better decisions. Established controlled data flows between automation, MES, and OSIsoft PI, supporting alarms, events, OEE review, electronic records, and process capability analysis. LEADERSHIP & AWARDS ISA/IEC 62443 Cybersecurity Fundamentals Specialist, recognized for regulated OT security preparation, 2025 Project Management Professional, recognized for disciplined multi project leadership, 2024 Lean Six Sigma Green Belt, recognized for practical process improvement and data analysis, 2023 EDUCATION Bachelor of Science in Electrical Engineering San Jose State University GPA: 4.0 2012 San Jose, CA Coursework: Control systems, industrial automation, electrical circuits, computer engineering CERTIFICATIONS ISA/IEC 62443 Cybersecurity Fundamentals Specialist 2025 Project Management Professional 2024 Lean Six Sigma Green Belt 2023 TECHNICAL SKILLS PLC and PAC Platforms: Rockwell, Siemens, Schneider HMI and SCADA: FactoryTalk, Ignition, Wonderware Control Programming: Ladder Logic, Structured Text, Function Block Manufacturing Systems: MES, ERP, PLM Data and Historians: OSIsoft PI, alarms, events Validation and Compliance: IQ, OQ, PQ, 21 CFR Part 11 Industrial Networking: Managed switches, VLANs, industrial firewalls OT Cybersecurity: IEC 62443, NIST, secure remote access Process Analytics: OEE, Cpk, SPC Quality and Risk: pFMEA, DMAIC, corrective action Project Delivery: FAT, SAT, commissioning Regulated Manufacturing: GMP, medical devices, audit support SKILLS Operational Technology Manufacturing Engineering PLC and PAC Controls Rockwell Controls Siemens Controls HMI and SCADA IEC 61131 3 MES Integration Industrial Networking OT Cybersecurity IQ OQ PQ Validation pFMEA and DMAIC SPC and Cpk Vendor Management Technical Communication PROFESSIONAL AFFILIATIONS International Society of Automation, member focused on controls, cybersecurity, and regulated manufacturing Project Management Institute, member supporting structured delivery, risk review, and stakeholder alignment Society of Manufacturing Engineers, participant in manufacturing automation and production improvement forums 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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