Automation & Validation Project Engineer (Medical Devices)

Ambu; Noblesville (IN); On-site; USD 95,000 - 150,000; Full time

Job summary

Ambu America is seeking a Project Engineer to lead automation and equipment capital projects at Noblesville, IN, with responsibility across Noblesville and Juarez sites. Travel up to 50% is anticipated as projects span locations.

You will manage automated manufacturing and assembly systems, deploy MES, SCADA, and IIoT platforms, ensure 21 CFR Part 820 compliance, and validate processes (IQ/OQ/PQ). A hands-on approach is required to streamline transfers and readiness.

Qualifications

• Bachelor’s degree in related field and 6-8 years of relevant work experience
• Five years’ experience in automation project management
• Five years’ experience working in the medical device field
• Strong background in medical device process validation, and regulatory compliance
• Ability to complete complex reports and correspondence
• Must be able to speak, read, write and understand English
• Bilingual in Spanish is preferred

Responsibilities

• Lead design and implementation of automated manufacturing and assembly systems
• Deploy smart factory solutions (MES, SCADA, IIoT) for real-time monitoring
• Lead automation and equipment capital projects from concept to installation and validation
• Hands-on involvement with process and equipment when needed
• Track and report project outcomes, savings, and KPIs
• Create and maintain engineering documentation and work instructions

Skills

Automation project mgmt

Regulatory compliance

Validation IQ/OQ/PQ

Lean Six Sigma

DFM/DFA

Bilingual Spanish

English proficiency

Education

Bachelor’s degree in related field

Tools

MES

SCADA

IIoT platforms

PLC/automation

Job description

Ambu America is seeking a Project Engineer to lead automation and equipment capital projects at Noblesville, IN, with responsibility across Noblesville and Juarez sites. Travel up to 50% is anticipated as projects span locations.

You will manage automated manufacturing and assembly systems, deploy MES, SCADA, and IIoT platforms, ensure 21 CFR Part 820 compliance, and validate processes (IQ/OQ/PQ). A hands-on approach is required to streamline transfers and readiness.