Senior Engineering/ IT Program Manager

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