Job Summary

The Senior Manager, Manufacturing Engineering (OT) is a hands-on leadership role responsible for managing the Operational Technology (OT) team that supports production of Insulet’s OmniPod insulin pump. This position leads the design, implementation, and maintenance of manufacturing systems including MES, PLC controls, industrial networks, databases, cybersecurity, and IT/OT infrastructure to ensure reliable, secure, compliant, and scalable manufacturing operations. The role partners closely with Manufacturing, Quality, IT, and external vendors, oversees OT projects and budgets, develops engineering talent, and remains actively involved in technical troubleshooting and system implementation. The ideal candidate has 10+ years of manufacturing controls or OT experience, prior people leadership experience, strong expertise in automation, industrial networking, cybersecurity, and regulatory compliance within a highly regulated manufacturing environment. This position is based onsite in Acton, MA with approximately 5–10% travel.

Job Title: Senior Manager, Manufacturing Engineering

Position Overview:
The Sr. Manager of Manufacturing Engineering for OT (including MES, Network, database and cybersecurity) will lead the team in enabling production of Insulet’s POD, an on-body insulin pump. The team is responsible to provide to production an IT/OT infrastructure that is capable, reliable, secure, compliant to regulatory requirements, and scalable globally. This role will lead cross-functionally, in collaboration with Production and IT, driving prioritized projects aligned with quality and business goals. The role is hands-on as a “Working Manager”.

Responsibilities
•   Build and enable the OT team to understand and meet the needs of business, with focus on the Manufacturing and Quality departments.
•   Drive team ownership toward measurable infrastructure performance that supports highly reliable data flow from the equipment to OEE and part traceability solutions, through the IT/OT layers to analytics, QMS and ERP platforms
•   Deep collaboration with System Integrators in the design and build of OT for existing and new production operations and sites
•   Drive the technical details to enable generation of eDHR
•   Strong knowledge of PLC functionality and programming, to include how PLC’s generate data
•   Leverage the analytical data and internal customer requests in aligning priorities.
•   Align cross-functionally to enable and control software access rights to run the production equipment, using training records as a condition of gaining access.
•   Development, training and motivation of Engineers. Propagate training to the Plant staff and others.
•   Engage with CSV and regulator teams to ensure compliance to GxP regulatory requirements such as FDA 21 CFR part 11
•   Collaborate with the IT department on handoffs, roles and responsibilities.
•   Work with Finance to secure project budgets and manage the work accordingly.
•   Personal execution of configuration, troubleshoot, and documentation of solutions
•   Active and early engagement in the development of requirements for new equipment and coordination with new equipment vendors
•   Leverage Smartsheet, Jira, Loop, or similar tools to manage the work, and to communicate the status, enablers and obstacles.
•   Other responsibilities as relevant and assigned.

Required Skills Competencies

•   Demonstrated leadership of teams with direct responsibility for enabling production.
•   Interpersonal skills effective in cross functional alignment toward common goals.
•   Extensive experience in engineering, design, development, debugging, commissioning and acceptance of manufacturing process software and/or OT for manufacturing
•   Formal responsibility for a Controls Engineering or IT/OT team and related budget.
•   Working knowledge of cybersecurity processes including zero trust. Collaborate with IT on security assessments. Drive the mitigations of priority risks identified.
•   GICSP (Global Industrial Cybersecurity Professional) certification preferred
•   Working knowledge of configuration of network switches such as Cisco, Stratix
•   Collaborate with the IT Firewall team on Palo Alto firewalls
•   Strong programming knowledge of Rockwell Automation RSLogix5000 and FTView ME and SE.
•   Working knowledge of ISA-95 network segmentation and security.
•   Ability to critically review OT engineering designs and ensure adherence to company design and development guidelines and SOP’s.
•   Working knowledge of visions systems such as Cognex and Keyence.
•   Intermediate/advanced SQL skills, comfortable manipulating/merging large datasets directly in the database.
•   Demonstrated proficiency in statistical analysis (hypothesis testing, regression modeling) and exposure to machine learning algorithms is a plus
•   Strong project management, organizational and documentation skills desired.
•   Ability to uphold Safety standards, to participate in Continuous Process Improvement on the job, and to follow our business best practices.
•   Knowledge of regulations including ISO 13485, ISO 14971, FDA 21 CFR part 820 and GDP.
•   Knowledge of Lean six sigma methods
•   Ability to work in a collaborative and dynamic team environment.

Education and Experience
•   Bachelor of Science in Computer Engineering with 12 years of experience, Mechanical Engineering, Electrical Engineering, Industrial Automation or related field. Or Master’s with seven (7) years of experience.
•   Minimum of ten (10) years of hands-on complex assembly and manufacturing equipment controls and/or OT experience including OT equipment design and implementation/improvement of network infrastructure
•   Experience managing engineering direct reports in Controls or IT/OT positions

Physical Requirements
•   Ability to lift up to 30 lbs.
•   Frequently standing, walking, reaching above shoulders and below waist.
Additional Information
•   The successful candidate will be expected to travel domestically and internationally. Anticipated travel is estimated at 5-10%.
•   The position is working on-site at our Acton, MA location.

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $149,900.00 - $224,900.00 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.

Insulet Corporation

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Sr Manager, Manufacturing Engineering (Onsite - Acton, MA)