Staff Controls Engineer NPI

Job Summary

The OT Technical Lead - NPI is a senior technical leader responsible for designing, integrating, and supporting the Operational Technology (OT) systems that power automated manufacturing equipment for new product introductions and manufacturing scale-up. This role bridges machine controls, manufacturing systems, and enterprise platforms by leading OT architecture, industrial networking, equipment connectivity, cybersecurity, and data integration initiatives. The ideal candidate brings deep expertise in industrial automation, PLC/HMI/SCADA systems, MES integration, OT infrastructure, and cross-functional leadership within a regulated manufacturing environment. Experience supporting medical device, pharmaceutical, or highly automated manufacturing operations is strongly preferred.

The OT Technical Lead - NPI provides technical leadership for the Operational Technology (OT) systems that connect, monitor, secure, and support automated manufacturing equipment for new product introduction and manufacturing scale-up initiatives. This Staff Engineer-level role is responsible for defining OT architecture, integration strategy, and lifecycle management to enable successful transition from development and pilot operations to commercial manufacturing.

Working closely with Manufacturing Engineering, Controls Engineering, IT, Cybersecurity, Quality, Operations, and external suppliers, this individual serves as the technical bridge between machine controls and enterprise systems, ensuring scalable, secure, and reliable manufacturing solutions.

Key Responsibilities

• Lead the OT strategy, architecture, and technical roadmap for NPI manufacturing programs.
• Design, implement, integrate, and support OT systems including HMI/SCADA platforms, industrial networks, data collection systems, historians, databases, and enterprise interfaces.
• Establish standardized connectivity between manufacturing equipment and higher-level systems including MES, SCADA, historians, databases, and industrial data platforms.
• Partner with IT and Cybersecurity to implement secure, scalable OT infrastructure, including networking, remote access, virtualized environments, backup, monitoring, and disaster recovery solutions.
• Drive equipment integration activities from specification through FAT, SAT, installation, validation, startup, and operational turnover.
• Lead resolution of complex technical issues spanning controls, communications, software, networking, and manufacturing applications.
• Develop and maintain OT standards, system documentation, interface specifications, network diagrams, and lifecycle management processes.
• Partner with Quality and Validation teams to ensure compliance with regulated manufacturing requirements.
• Evaluate emerging technologies and lead continuous improvement initiatives that enhance system reliability, scalability, maintainability, and security.
• Provide technical leadership and mentoring across engineering, operations, and maintenance teams.

Basic Requirements (Must Have)

• 8+ years of hands-on experience in industrial automation, controls engineering, or OT systems within a manufacturing environment.
• Proven experience designing and integrating OT systems connecting PLC, HMI/SCADA, MES, historians, databases, and industrial data platforms for automated manufacturing operations.
• Strong expertise with industrial networking and communications, including EtherNet/IP, OPC UA, MQTT, TCP/IP, VLANs, managed switches, firewalls, and secure remote access.
• Demonstrated success leading cross-functional OT initiatives involving Manufacturing Engineering, Controls Engineering, IT, Cybersecurity, Quality, and external equipment suppliers/integrators.
• Bachelor's degree in Electrical Engineering, Computer Engineering, Computer Science, Automation Engineering, or a related technical discipline.

Preferred Qualifications

• Experience with Rockwell Automation platforms including Studio 5000, Logix, FactoryTalk, or comparable PLC, HMI, and SCADA systems.
• Experience with Industrial DataOps platforms such as Litmus, HighByte, HiveMQ, or equivalent industrial data technologies.
• Knowledge of ISA-95, Unified Namespace (UNS), and advanced manufacturing data architecture concepts.
• Experience with Windows Server, Active Directory, virtualization, storage, backup, and OT infrastructure administration.
• Experience using Python, PowerShell, SQL, or similar scripting and automation tools.
• Knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), Computer Software Assurance (CSA), and data integrity requirements.
• Experience supporting medical device, pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Experience supporting new product introductions, manufacturing scale-up initiatives, and automated assembly systems.

Additional Information

• Ability to work in a Class 8 cleanroom environment as needed.
• Position is based in Acton, Massachusetts, with an expectation of at least four days per week onsite.
• Approximately 10-20% travel, including domestic and international travel to manufacturing sites, suppliers, and system integrators.

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $141,600.00 - $212,400.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.