Automation Project Lead for Medical Device Manufacturing

Ambu A/S; Philadelphia (Philadelphia County); On-site; USD 110,000 - 160,000; Full time

Job summary

Ambu A/S in Philadelphia seeks a Project Manager to lead automation, equipment, and smart manufacturing initiatives in a regulated medical device environment, from concept through validation and handoff. You will partner with Engineering, Manufacturing, Quality, Regulatory, and Supply Chain to develop plans, manage budgets and schedules, and ensure on-time delivery, quality, and regulatory compliance.

The role focuses on risk management and deploying MES/SCADA/IIoT to improve traceability,

Qualifications

• Bachelor's degree in Engineering, Manufacturing, Project Management, or related field.
• 6–8 years of progressive project management experience in a manufacturing environment.
• 5+ years of experience leading automation and equipment capital projects.
• 5+ years of experience within the medical device industry with automated manufacturing.
• Experience managing budgets, schedules, resources and risk mitigation.
• Experience with automation technologies such as robotics, PLCs, vision systems, and smart manufacturing solutions.
• Knowledge of FDA QSRs (21 CFR Part 820) and ISO 13485; strong communication skills.

Responsibilities

• Lead automation and equipment capital projects from concept through validation and production readiness.
• Develop and manage project plans, timelines, budgets, resources, risks, and deliverables.
• Coordinate cross-functional teams including Engineering, Manufacturing, Quality, Validation, Regulatory Affairs, Supply Chain, and Operations.
• Manage relationships with equipment manufacturers, system integrators, and external suppliers to meet requirements.
• Drive project governance with reviews, status updates, risk assessments, and stakeholder communications.
• Track and report project performance, savings, ROI, and KPIs.
• Ensure projects are completed safely, within scope, on schedule, and within budget.
• Lead implementation of automated manufacturing systems including robotics, PLCs, vision systems, motion control, and inspection equipment.
• Support MES, SCADA, IIoT, data analytics deployments and smart manufacturing technologies.
• Collaborate to identify automation opportunities to improve quality, throughput, traceability, and efficiency.
• Facilitate FAT, SAT, installation, commissioning, and startup activities.
• Maintain engineering documentation, project records, specs, procedures, and standard work.
• Ensure compliance with regulatory and quality requirements; drive DFM/DFA where applicable.
• Oversee validation planning and execution (IQ/OQ/PQ); support process validation and change control.
• Ensure audit-ready project documentation and continuous improvement initiatives.

Skills

Project management

Leadership

Communication

Regulatory compliance

Risk management

Lean Six Sigma

PMP certification

Education

Bachelor's degree in Engineering, Manufacturing, Project Management, or related field

Job description

Ambu A/S in Philadelphia seeks a Project Manager to lead automation, equipment, and smart manufacturing initiatives in a regulated medical device environment, from concept through validation and handoff. You will partner with Engineering, Manufacturing, Quality, Regulatory, and Supply Chain to develop plans, manage budgets and schedules, and ensure on-time delivery, quality, and regulatory compliance.

The role focuses on risk management and deploying MES/SCADA/IIoT to improve traceability,