Staff OT Manufacturing Engineer- Shockwave

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); On-site; USD 109,000 - 174,800; Full time

Benefits offered by this job

401(k) plan

Long‑term incentive program

Vacation time 120 hours/year

Job summary

Johnson & Johnson is seeking a Staff OT Manufacturing Engineer in Santa Clara to design, implement, validate, and support OT solutions for safe, compliant manufacturing. You will lead PLC/SCADA/DCS and MES interfaces, ensure regulatory documentation, and drive IT/OT integration across sites.

Responsibilities include system validation (IQ/OQ/PQ), risk assessment, vendor management, and cross-functional collaboration with IT, Quality, and Production. Travel to sites as needed.

Qualifications

• Bachelor’s degree in Electrical/Controls/Automation, etc.

Responsibilities

• Design, develop, deploy PLC/HMI/SCADA and control logic for manufacturing processes.
• Lead OT for process/tool/fixture implementations; specify requirements and manage vendor deliverables.
• Plan and execute IQ/OQ/PQ validation for control systems and MES/SCADA integrations.
• Integrate OT with MES/ERP/PLM and support data migration and electronic records integrity.
• Implement secure OT networks with IT/cybersecurity; align with IEC 62443 and NIST.

Skills

OT security

Industrial networking

Cross-functional leadership

Root cause analysis

Regulatory documentation

Vendors & integrators management

Education

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

Tools

Rockwell

Siemens

Schneider

Ignition

FactoryTalk

Wonderware

IEC 61131‑3 languages

ISA95 interfaces

Job description

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.

Requirements

• 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, FactoryTalk, Wonderware) and fluency with IEC 61131‑3 languages (Ladder, Structured Text, Function Block).
• OT–IT integration expertise: MES/ERP/PLM interfaces, ISA95 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 IEC62443 and NIST guidance.
• Experience with regulatory‑grade system validation and documentation (IQ/OQ/PQ, validation plans/protocols/trace matrices, deviation handling) and awareness of 21CFRPart11 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: IEC62443 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., OSIsoftPI).
• 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.

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 Section503 of the Rehabilitation Act.

Pay and Benefits

Anticipated base pay range: $109,000.00 – $174,800.00.

Eligible for the Company’s consolidated retirement plan (401(k) pension) and long‑term incentive program.

Typical benefits include:

• Vacation – 120 hours per calendar year
• Sick time – 40 hours (state‑specific variations)
• Holiday pay – 13 days per year (incl. floating holidays)
• Work, Personal and Family Time – up to 40 hours (annual)
• Parental Leave – up to 480 hours within one year of birth/adoption/foster care
• Bereavement Leave – 240 hours (24 hours per extended family member per 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 year

For additional general information on Company benefits, please visit https://www.careers.jnj.com/employee-benefits.