Global Medical Device Program Lead

Katalyst-Healthcares-

Worcester (MA)

On-site

USD 140,000 - 190,000

Full time

3 days ago
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Job summary

Katalyst-Healthcares- is seeking a Manufacturing Program Manager to lead complex global programs for medical devices and drug-device combinations in Worcester, MA. This role focuses on strategy, planning, risk management, and cross-functional coordination to meet milestones and budgets.

The candidate will work with Manufacturing, Engineering, S&T, Supply Chain, Quality, and Regulatory to drive transfers, readiness, and launches.

Qualifications

  • Bachelor's degree in Engineering, Science, or related discipline; advanced degree preferred.
  • 10+ years in regulated manufacturing, medical device, engineering, or technical operations.
  • At least 5 years in global program/project management.
  • Experience in device manufacturing, combination product packaging, or related environment.
  • Experience with product transfers from development to manufacturing operations.
  • NPI, manufacturing readiness, and product launches experience.
  • Strong cross-functional execution, stakeholder alignment, and risk management.
  • Proficiency in MS Excel, MS Project, PowerPoint, Teams, and SharePoint.
  • Excellent communication, organizational, presentation, negotiation, and leadership skills.
  • Willingness to travel domestically and internationally.

Responsibilities

  • Define program scope, execution strategies, resources, timelines, and milestones.
  • Lead global manufacturing programs involving assembly, labeling, packaging, testing, storage, and product release.
  • Develop and maintain integrated schedules, Gantt charts, milestone plans, and WBS.
  • Coordinate product and manufacturing transfers from development to commercial operations.
  • Facilitate global kickoff meetings, governance, reviews, and cross-functional planning.
  • Align manufacturing sites and global teams for program execution.
  • Coordinate material planning, sourcing, distribution, and supply readiness.
  • Manage program budgets and monitor financial performance.
  • Identify risks, develop mitigation, and implement contingency plans.
  • Coordinate with Quality and Regulatory for submissions, approvals, and launches.
  • Track progress, resolve barriers, and report risks to leadership.
  • Prepare charters, RACI, risk registers, milestone tables, and executive presentations.
  • Identify opportunities to improve efficiency, cut costs, and accelerate timelines.
  • Ensure proper closeout and transition of responsibilities.

Skills

Project management
Cross-functional coordination
Risk management
MS Excel
MS Project
PowerPoint
Teams
SharePoint
Leadership
Communication

Education

Bachelor's degree in Engineering or Science
Advanced degree preferred

Tools

MS Excel
MS Project
PowerPoint
Teams
SharePoint
Power BI
Smartsheet
AI productivity tools

Job description

Katalyst-Healthcares- is seeking a Manufacturing Program Manager to lead complex global programs for medical devices and drug-device combinations in Worcester, MA. This role focuses on strategy, planning, risk management, and cross-functional coordination to meet milestones and budgets.

The candidate will work with Manufacturing, Engineering, S&T, Supply Chain, Quality, and Regulatory to drive transfers, readiness, and launches.

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