Project Manager (Manufacturing Engineering)

Role and Responsibilities

• Lead assigned projects from authorization through implementation and formal closure, defining scope, objectives, deliverables, milestones and completion criteria with sponsors and stakeholders.
• Develop and maintain project schedules identifying activities, dependencies, owners and due dates, and set a review cadence based on complexity, urgency and business impact.
• Track actions, decisions, deliverables and open issues to completion, holding team members accountable for agreed commitments and dates.
• Identify and escalate schedule delays, resource constraints and unresolved dependencies to the appropriate functional or site leadership.
• Provide regular status reports on progress, milestones, open actions and risks; verify deliverables are accepted before closure and document lessons learned.
• Lead structured root-cause and corrective-action projects, facilitating problem-solving with methods such as 8D, DMAIC, 5 Whys, cause-and-effect or fault-tree analysis.
• Ensure the team establishes a clear problem statement, containment plan, investigation strategy and measurable success criteria.
• Coordinate data collection, testing and technical analysis, ensuring actions are assigned to qualified subject-matter experts.
• Drive timely containment, root-cause analysis, corrective-action implementation and effectiveness verification supported by objective evidence.
• Escalate stalled investigations or unresolved disagreements and support investigation summaries, reports and presentations; technical experts remain responsible for technical conclusions.
• Cross-functional coordination: Coordinate activities and resource needs across Engineering, Quality, Operations, Materials, Maintenance, Purchasing, Customer Service and other functions.
• Run project meetings—agendas, decisions and action items—and manage dependencies so one group's work does not unnecessarily delay another's.
• Carefully coordinate supplier schedules, technical reviews, quotations, deliverables, installations and open actions.
• Carefully coordinate customer and external communication through the appropriate Program Management, Customer Service, Quality or commercial representative, and document decisions and scope or timing changes.
• Validation and implementation support: Support validation and qualification planning by coordinating schedules, resources, prerequisites and required deliverables.
• Track equipment qualification, process validation, inspection, documentation, training and production-readiness activities, and coordinate implementation with Engineering, Quality and Operations.
• Identify and escalate open items affecting production release, and support transition of completed projects to the responsible owner once documentation and training are complete.

Qualifications

• Strong project-planning, organization and follow-through skills, with the ability to manage multiple projects and competing priorities.
• Ability to lead cross-functional teams without direct authority; experience leading cross-functional technical or operational projects required.
• Strong meeting-facilitation, action-management and written and verbal communication skills, including clear reporting of status, risks and decisions to management.
• Working knowledge of structured root-cause and corrective-action methods; experience with root-cause analysis, corrective action or continuous improvement required.
• Working knowledge of manufacturing processes, process validation, equipment qualification, change control and quality-system requirements preferred.
• Ability to challenge assumptions respectfully and maintain accountability.
• Proficiency with Microsoft Project or comparable scheduling software.
• Proficiency with Microsoft Excel, PowerPoint and other project-reporting tools; project-management, Lean, Six Sigma or structured problem-solving training preferred.

Education Requirements

• A bachelor's degree in engineering or a related technical discipline and a minimum of three to five years' engineering experience in a manufacturing environment is required.
• Experience in a medical-device, pharmaceutical or another regulated manufacturing environment is strongly preferred.