Project Validation Engineer, Advanced Manufacturing

Ambu A/S; Noblesville (IN); On-site; USD 110,000 - 150,000; Full time

Job summary

Ambu A/S in Noblesville, Indiana seeks a Project Validation Engineer in Advanced Manufacturing to lead automation projects and validate new equipment for production. The role covers Noblesville and Juarez sites, with up to 50% travel. Strong focus on FDA/ISO compliance and process validation.

The ideal candidate has a bachelor’s degree and 6–8 years in automation, plus 5 years in medical devices, with hands‑on problem solving and cross‑site coordination.

Qualifications

• Bachelor’s degree and 6–8 years of relevant experience in manufacturing or automation.
• Five years’ experience managing automation projects.
• Five years’ experience in the medical device field.
• Strong background in process validation and regulatory compliance.
• Excellent reporting and written communication skills.
• English fluency; bilingual in Spanish preferred.

Responsibilities

• Lead automation and equipment capital projects from concept to installation and validation.
• Collaborate with suppliers and internal teams to deploy automated manufacturing solutions.
• Ensure readiness and validation of new equipment (IQ/OQ/PQ) for production.
• Track savings, KPIs, and project outcomes; maintain engineering documentation.

Skills

Process validation

Regulatory compliance

Documentation

Leadership

Communication

Education

Bachelor's degree in related field

Tools

PLCs

Vision systems

MES

SCADA

IIoT

Job description

Project Validation Engineer, Advanced Manufacturing

City: Noblesville, State: Indiana, Country/Region: United States. Business Area: Production. Department: Production, NV – IE. Employment Type: Full‑time. Req ID: 10360.

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 for 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.
  • Comply 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.