Automation SME

•Architected AI based labeling automation solutions across regulated manufacturing, packaging, and labeling operations.•Applied deep understanding of medical device and IVD labeling processes, including content authoring, approval, printing, inspection, and reconciliation.•Designed automation workflows tightly integrated with PLM, MES, ERP, and QMS systems to enable end to end label lifecycle management.•Implemented AI/ML, computer vision, and NLP techniques to automate label validation, defect detection, compliance checks, and change impact analysis.•Ensured alignment with global regulatory requirements such as UDI, IFU, translations, market specific variants, and FDA/EU MDR expectations.•Built scalable, secure, and audit ready architectures supporting CSV/GxP validation and regulatory traceability.•Considered shop floor realities including line clearance, rework handling, deviation management, and minimal disruption to production.•Established architecture standards, reference designs, and governance for labeling automation and AI solution scalability.•Collaborated closely with manufacturing, quality, regulatory, and IT stakeholders to align technical solutions with operational needs.•Translated complex AI and automation designs into clear business, compliance, and risk narratives for leadership and program teams.•Drove cross functional design reviews, change impact assessments, and stakeholder alignment across manufacturing sites.•Ensured solutions supported long term product lifecycle evolution, regulatory updates, and portfolio wide scalability.Paid Leave, Health Insurance, Group life insurance, Disability, 401(K)The expected salary range for this position is between $55,000 to $1,00,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.

Created: 2026-05-10