OT Manufacturing Engineer- Shockwave
Job in
Santa Clara, Santa Clara County, California, 95053, USA
Listed on 2026-07-18
Listing for:
6947-SHOCKWAVE MEDICAL INC. Legal Entity
Full Time
position Listed on 2026-07-18
Job specializations:
-
Manufacturing / Production
Systems Engineer, Automation & Mechatronics Engineer
Job Description & How to Apply Below
Position Overview
The Staff Operational Technology (OT) Manufacturing Engineer is responsible for designing, implementing, validating, and supporting operational technology solutions that enable safe, compliant, and efficient manufacturing operations. This role focuses on industrial control systems, automation, OT–IT integration, and lifecycle support of PLC/SCADA/DCS systems and MES interfaces for on‑market products.
Essential Job Functions- Design, develop, program, and deploy industrial control systems (PLCs, PACs), HMI/SCADA applications, and control logic to support manufacturing processes.
- Lead OT for process/tool/fixture implementations; define functional/user requirements, system specifications, manage vendor deliverables, and provide on‑site commissioning, ramp support, and operator/maintainer training.
- Plan and execute system validation activities (IQ/OQ/PQ) for control systems, sequencing logic, and MES/SCADA integrations while ensuring documentation meets regulatory requirements.
- Integrate OT systems with MES/ERP/PLM systems, support data migration, and ensure electronic records integrity.
- Implement and maintain secure, segmented OT networks with IT/cybersecurity; lead OT cyber risk management aligned to IEC 62443 and NIST.
- Troubleshoot production control issues, perform root cause analysis (DMAIC), and implement corrective actions to restore and improve process stability and throughput.
- Develop and maintain control system documentation: control logic descriptions, wiring diagrams, I/O lists, HMI screen specs, SOPs, and validation records.
- Lead or participate in pFMEA and risk assessments focused on control and automation risks; translate risk findings into mitigation actions and design changes.
- Conduct capability studies and process monitoring where OT systems provide process control data (Cpk analyses, SPC implementations).
- Manage vendor relationships for control system components, PLC/HMI platforms, and system integrators; review and accept vendor deliverables.
- Participate in continuous improvement projects to increase automation reliability, reduce downtime, and support scalability.
- Other duties as assigned.
- Bachelor’s degree in Electrical, Controls, Automation, Mechatronics, Computer, or Mechanical Engineering;
Master’s preferred. - Minimum 8 years of manufacturing engineering experience, including 3–5 years hands‑on OT/control systems in regulated environments.
- Proven leader of OT projects across the full lifecycle: requirements, architecture, PLC/HMI/SCADA development, vendor selection, commissioning, IQ/OQ/PQ validation, and post‑ramp sustainment.
- Advanced PLC/HMI/SCADA proficiency across major platforms (Rockwell, Siemens, Schneider, Ignition, Factory Talk, Wonderware) and fluency with IEC 61131‑3 languages (Ladder, Structured Text, Function Block).
- OT–IT integration expertise: MES/ERP/PLM interfaces, ISA
95 application, recipe/batch management, historians, real‑time alarms/events, and OT sourced OEE/Cpk reporting. - OT security and industrial networking skills: network segmentation, managed switches/VLANs, industrial firewalls, secure remote/vendor access, vulnerability/patch management, and familiarity with IEC
62443 and NIST guidance. - Experience with regulatory‑grade system validation and documentation (IQ/OQ/PQ, validation plans/protocols/trace matrices, deviation handling) and awareness of 21
CFRPart
11 concepts for electronic records. - Strong troubleshooting and root‑cause capabilities for PLC logic, HMI behavior, communication faults, and on‑site commissioning diagnostics.
- Strong vendor and integrator management skills: scoping, technical acceptance, FAT/SAT oversight, and contract deliverable governance.
- Demonstrated ability to lead cross‑functional teams, mentor junior OT/control engineers, and influence stakeholders including IT, Quality, Production, and Regulatory.
- Excellent written and verbal communication skills; experienced producing technical specifications, control narratives, validation artifacts, SOPs, and executive summaries.
- Willingness and ability to travel to manufacturing sites as required.
- Certifications:
IEC
62443 practitioner/certification,…
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