Automation Project Manager - Smart Manufacturing

Ambu; Noblesville (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Ambu seeks a Project Manager to lead automation, equipment, and smart manufacturing initiatives within a regulated medical device environment. From concept to validation and handoff, you will ensure delivery on time, within budget, and compliant with FDA QSR and ISO standards.

You will coordinate with Engineering, Manufacturing, Quality, Validation, and Regulatory Affairs to implement robotics, PLCs, MES, SCADA, and IIoT solutions that improve quality and efficiency while maintaining

Qualifications

• Bachelor's degree as stated in the ad.
• 6–8 years progressive project management experience in manufacturing.
• 5+ years leading automation and equipment capital projects.
• 5+ years in the medical device industry with automated manufacturing.
• Experience with robotics, PLCs, vision systems, and smart manufacturing.
• Strong knowledge of PM methodologies and tools.
• Excellent written and verbal communication; executive reporting.
• Experience with FDA QSR 21 CFR Part 820, ISO 13485, ISO 14971; bilingual a plus.

Responsibilities

• Lead automation and equipment capital projects from concept through installation, 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 suppliers.
• 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, on schedule, and within budget.
• Lead implementation of automation systems, including robotics, PLCs, vision, and inspection equipment.
• Support MES, SCADA, IIoT deployments and data analytics.

Skills

Project management

Cross-functional leadership

Budget management

Regulatory compliance

Communication skills

Education

Bachelor's degree in Engineering/Manufacturing/PM or related field

PM Certification (PMP) preferred

Tools

MES

SCADA

IIoT

Data analytics

Job description

Ambu seeks a Project Manager to lead automation, equipment, and smart manufacturing initiatives within a regulated medical device environment. From concept to validation and handoff, you will ensure delivery on time, within budget, and compliant with FDA QSR and ISO standards.

You will coordinate with Engineering, Manufacturing, Quality, Validation, and Regulatory Affairs to implement robotics, PLCs, MES, SCADA, and IIoT solutions that improve quality and efficiency while maintaining