Staff OT Manufacturing Engineer- Shockwave

Shockwave Medical; Santa Clara (CA); On-site; USD 109,000 - 174,800; Full time

Benefits offered by this job

Vacation 120h/yr

Sick time 40h/yr

Holiday pay 13 days/yr

Parental Leave 480h/yr

Job summary

Johnson & Johnson is seeking a Staff OT Manufacturing Engineer to design, validate, and support OT solutions for compliant production environments. This role focuses on PLC/SCADA/DCS, MES interfaces, and OT–IT integration, partnering with R&D, Quality, Production, IT, and Supply Chain.

You will lead design, validation (IQ/OQ/PQ), system integration with MES/ERP/PLM, and security for OT networks, with travel to manufacturing sites.

Qualifications

• Minimum 8 years manufacturing engineering experience with 3–5 years hands-on OT/control systems in regulated environments.
• Proven leader of OT projects across full lifecycle: requirements, architecture, PLC/HMI/SCADA development, vendor selection, commissioning, IQ/OQ/PQ validation, and post ramp sustainment.
• Fluent with IEC 61131‑3 languages (Ladder, Structured Text, Function Block) and OT–IT integration (MES/ERP/PLM interfaces).

Responsibilities

• Design, develop, program, and deploy industrial control systems (PLCs, PACs), HMI/SCADA applications, and control logic.
• Lead OT for process/tool/fixture implementations: define functional/user requirements, system specs, vendor management, on-site commissioning, ramp support, and operator training.
• Plan and execute IQ/OQ/PQ validations for control systems, sequencing logic, and MES/SCADA integrations; ensure documentation meets regulatory requirements.
• Integrate OT systems with MES/ERP/PLM systems and support data migration and electronic records integrity.
• Implement and maintain secure, segmented OT networks with IT/cybersecurity; lead OT risk management aligned to IEC 62443 and NIST.
• Troubleshoot production control issues, perform root cause analysis, and implement corrective actions.
• Develop and maintain control system documentation: narratives, wiring diagrams, I/O lists, SOPs, and validation records.
• Lead or participate in pFMEA and risk assessments; translate findings into mitigations and design changes.
• Conduct capability studies and process monitoring where OT provides control data (Cpk, SPC).
• Manage vendor relationships and review vendor deliverables; oversee FAT/SAT.
• Participate in continuous improvement projects to increase automation reliability and scalability.

Skills

OT security

OT–IT integration

PLCs/HMI/SCADA

Regulated manufacturing

Cross-functional leadership

Education

Bachelor’s in Electrical/Controls/Automation/Mechatronics/Computer/Mechanical Engineering

Master’s preferred

Tools

Rockwell

Siemens

Schneider

Ignition

FactoryTalk

Wonderware

Job description

Job Function: Supply Chain Engineering

Job Sub Function: Manufacturing Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Santa Clara, California, United States of America

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. The Staff OT Engineer partners with R&D, Quality, Production, IT, and Supply Chain to ensure robust control systems, validated processes, and secure, reliable production operations.

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 and 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; ensure documentation meets regulatory requirements.
• Integrate OT systems with MES/ERP/PLM systems (data handshakes, batch records, recipe management), support data migration and ensure electronic records integrity.
• Implement and maintain secure, segmented OT networks with IT/cybersecurity; lead OT cyber risk management (vulnerabilities, patching/compensating controls, access controls, incident response) 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.

Requirements

• Bachelor’s in Electrical/Controls/Automation/Mechatronics/Computer/Mechanical Engineering. Master’s preferred.
• Minimum 8 years’ manufacturing engineering experience, including 3–5 years hands on OT/control systems in regulated environments (medical device/pharma preferred).
• 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 (e.g., Rockwell, Siemens, Schneider, Ignition, FactoryTalk, Wonderware) and fluent 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 CFR Part 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.

Preferred Qualifications

• Certifications: IEC 62443 practitioner/certification, GICSP, ISA, vendor‑specific PLC/HMI certifications, or relevant OT security credentials.
• Formal project management certification (PMP) or equivalent demonstrated multi‑project leadership experience.
• Experience with implementation of historians (e.g., OSIsoft PI).
• Experience designing and implementing architecture for SCADA or an OT communication layer, that delivers centralization of IOT data and supports cloud‑based OT analytics platforms.
• Prior experience in medical device or pharmaceutical manufacturing with direct support for audits and regulatory submissions.
• Six Sigma or Lean certification and experience applying statistical methods (Cpk, SPC) using Minitab or similar tools to OT‑sourced process data.

Benefits

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52‑week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time‑Off – 80 hours per calendar year

Pay Transparency

Anticipated base pay range for this position: $109,000.00 – $174,800.00

EEO Statement

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.