Project Validation Engineer, Advanced Manufacturing

This role will be based out of the Ambu America's Center of Excellence located at the Noblesville, Indiana manufacturing facility. The role has responsibility for Advanced Manufacturing Engineering functions of both the Noblesville, IN and the Juarez, MX manufacturing sites. The expected travel for this role is up to 50%.

Role Summary:

The Project Engineer leads Automation and Equipment Capital projects, deals with suppliers, supports the development of automated solutions, is responsible of the new equipment installation and validation, ensuring seamless process transfer and readiness.

Key Responsibilities and Essential Functions:

• Automation & Smart Manufacturing:
  • Lead the design and implementation of automated manufacturing and assembly systems (e.g., robotics, PLCs, vision systems, motion control) to support precision, repeatability, and compliance.
  • Deploy smart factory solutions, including MES, SCADA, and IIoT platforms, to enable real-time monitoring, traceability, and predictive analytics.
  • Lead automation and equipment capital projects from concept to installation and validation.
  • The role requires to be “hands on”, on the process and equipment, when needed.
  • Tracks and reports project outcomes, savings, and key performance indicators (KPIs).
  • Create and maintain engineering documentation, including drawings, work instructions, and standard work.
• Compliance and Validation:
  • Validation Documents preparation and execution, to ensure all automated systems are validated (IQ/OQ/PQ) and fully compliant with 21 CFR Part 820 and other applicable standards, before release to production.
  • Complying with FDA QSR, ISO 13485, and relevant product-specific regulations (e.g., IEC 60601, ISO 14971).
  • Operational & Regulatory Excellence

 

• Operational Excellence:
  • Champion Lean, Six Sigma, and Design for Manufacturability (DFM/DFA) principles across internal and outsourced operations.

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

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.