Automation & OT Digital Engineer

Location: USA PR - Humacao

Remote Type: Onsite

Time Type: Full time

Job Description

Job Description Summary

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the creativity and passion of all of us—from building and engineering to manufacturing and marketing our billions of MedTech products per year. We look at the impossible and find transformative solutions that turn dreams into possibilities.  

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Job Summary:

This role unifies industrial automation, operational technology (OT), and digital development with software validation to support compliant, reliable, and secure manufacturing within the healthcare device sector. You will design and maintain Rockwell-based automation systems (PLC/HMI/SCADA/Historians), architect secure OT networks, and build validated digital solutions (apps/integrations/data services). You’ll work with Operations, Quality/QA, IT, and Supply Chain. You will ensure adherence to FDA regulations (21 CFR Parts 820 & 11) and ISO 13485. You will also provide outstanding support to production users.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

1) Automation Systems Engineering (Rockwell Focus)

• Compose, program, commission, and optimize Rockwell automation: ControlLogix/CompactLogix (Studio 5000), PanelView (FactoryTalk View Machine Edition/Standard Edition), FactoryTalk Linx and FactoryTalk Historian.

• Implement/troubleshoot standards for alarms, interlocks, safety functions, batch/recipe control, and audit-ready configurations.

• Integrate vision systems, robotics, and motion control where applicable; ensure proper I/O, network, and asset lifecycle management.

• Conduct root cause analysis (RCA) and corrective actions to minimize downtime; support preventive maintenance and spare parts strategy.

2) OT Networks & OT Manufacturing Equipment

• Understand segmented OT networks (VLANs, firewalls, DMZs, remote access), and support operational technology machinery used at the facility.

• Build and maintain OT equipment inventory.

• Monitor and respond to events impacting availability, integrity, and confidentiality across OT assets (PLCs, HMIs, pcs, servers, historians).

3) Digital Development & Integration

• Design and develop applications, APIs/microservices, scripts, and data pipelines that integrate MES/SCADA/ERP (JD Edwards)/Oracle databases/Cloud.

• Build clean, modular, secure code; manage version control and releases (Git, Azure DevOps/GitLab), with CI/CD and quality gates (linting, tests, SAST/DAST).

• Create dashboards and data models (SQL/NoSQL, historians) for operations, quality, maintenance, and leadership.

• Automate data handling/reporting using Smartsheet, Visual Basic/VBA (e.g., Excel add-ins, macros) and scripting for repeatable compliance outputs.

4) Software Validation & Regulatory Compliance (FDA/CSV)

• Lead and implement CSV/SDLC deliverables: Validation Plan, Risk Assessment, URS/FRS/SRS, Design Specs, Traceability Matrix, Test Protocols (unit/system/UAT), Final Report.

• Ensure 21 CFR Part 11 compliance (electronic records/signatures): outstanding IDs, audit trails, access control, backup/restore, and accuracy and reliability of data (ALCOA+).

• Align with ISO 13485, ISO 14971 risk management.

• Own change control, configuration management, release notes, periodic reviews, and re-validation after changes; support deviation/CAPA workflows as needed.

5) ERP/MES/Business Systems

• Integrate and support JD Edwards (JDE) for work orders, BOM/routings, inventory, and manufacturing execution—building robust data flows to/from OT/MES/SCADA.

• Work with Oracle (EBS/Cloud/DB): queries, stored procedures, interfaces, and data integrity checks.

• Use Smartsheet for project tracking, intake forms, dashboards, and automation (notifications, approvals); standardize templates and metrics.

6) Project Management & Customer Service

• Plan and deliver projects using PM protocols (charter, schedule, budget, risks, collaborator plan); maintain RAID logs and stage gates.

• Coordinate vendors and cross-functional teams; prepare commissioning/startup plans and cutover runbooks.

• Provide responsive, professional customer service to production users: clear communications, expectations management, and timely resolution with empathy.

• Develop SOPs, work instructions, user guides, and training materials; facilitate UAT and user onboarding.

Education and Experience:

• Bachelor’s degree or equivalent experience in Electrical/Computer Engineering, Mechatronics, Computer Science, or a related field.

• 5+ years in industrial automation/OT and software/digital development in a regulated medical device environment.

• Hands-on proficiency with:

  • Rockwell Automation: Studio 5000, FactoryTalk View ME/SE, FactoryTalk Historian, PlantPAx, ControlLogix/CompactLogix, PanelView.

  • Protocols: Ethernet/IP.

  • Networking: TCP/IP, VLANs, firewalls, VPN/remote access.

  • Development: C#/.NET, Python, JavaScript/TypeScript (Node.js/React), SQL; Visual Basic/VBA for automation/reporting.

  • Validation/Testing: authoring CSV documentation; frameworks such as NUnit/xUnit/JUnit/PyTest.

• Experience with JD Edwards and Oracle (queries, integrations); Smartsheet for PM and reporting.

• Strong troubleshooting, documentation, and cross-functional communication skills; customer-service mindset.

Knowledge and Skills:

• Experience with MES, historians (e.g., PI, FactoryTalk Historian), and IIoT/edge platforms.

• Familiarity with ISO 13485, ISO 14971 and 21 CFR Parts 820 & 11.

• PMP or equivalent PM certification; Lean/Six Sigma exposure.

• Bilingual (Spanish/English) strongly preferred, Spanish is required.

Work Environment: (if applicable)

• On-site/hybrid with regular shop-floor presence; PPE and safety adherence required.

• Off-hours support may be needed for cutovers/startups or critical incidents.

• Occasional travel for vendor coordination, training, or site support.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers 

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

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