Three Point Solutions, Inc.

Job Title: Senior Engineering/ IT Program Manager Client: Medical Device Manufacturing Company Duration: 12 Months Location: 100% Remote (Travel to Ponce, Puerto Rico as needed) Role Overview Lead large cross-functional engineering programs Support manufacturing, digital transformation, and regulated systems Work across Engineering, Manufacturing, Quality, Regulatory, and IT Program Leadership Manage enterprise engineering programs Build roadmaps, milestones, and resource plans Deliver within scope, time, and budget Manufacturing and Systems Lead MES and automation initiatives Oversee CSV, IQ/OQ/PQ validation Ensure FDA, ISO 13485, GxP, 21 CFR Part 11 compliance Support digital manufacturing transformation Risk and Compliance Maintain RAID logs Drive risk mitigation Ensure audit readiness Cross-Functional Lead global engineering teams Manage stakeholders Escalation point for risks and constraints Governance and Reporting Executive status reporting Maintain program plans and documentation Track budget and financials Required Qualifications Bachelor's in Engineering / CS 10 years in regulated industries (Med Device / Pharma) Strong in MES, CSV, automation Regulatory knowledge (FDA, GxP, Part 11) Large team leadership (50 preferred) Agile and Waterfall experience Enterprise-scale program delivery Willing to travel to Puerto Rico Preferred PMP or Scrum Master Global manufacturing deployments ERP / SAP / LIMS exposure Site expansion or transfer programs Digital transformation or PMO background Key Skills Executive communication Stakeholder management Strategic roadmaps Regulatory mindset Budget control Change management Influence without authority Responsibilities Lead large cross-functional engineering programs Support manufacturing, digital transformation, and regulated systems Work across Engineering, Manufacturing, Quality, Regulatory, and IT