Senior Manager, Advanced Manufacturing Engineering

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

Objective

This position leads the development and deployment of advanced manufacturing solutions for medical devices, with a strong focus on project management, automation, and real-time data monitoring. This role is instrumental in scaling production capabilities while maintaining compliance with FDA regulations and ISO 13485 standards

Responsibilities And Essential Functions

Strategic Leadership

• Lead a multidisciplinary team of engineers focused on automation and process development
• Define and execute a strategic roadmap for advanced manufacturing technologies to support product pipeline growth and regulatory compliance.
• Serve as the manufacturing engineering lead for major projects, ensuring process transfer readiness
  
  

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.
• Partner with Quality to ensure automated systems are validated (IQ/OQ/PQ) and fully compliant with 21 CFR Part 820 and other applicable standards.
  
  

Operational & Regulatory Excellence

• Champion Lean, Six Sigma, and Design for Manufacturability (DFM/DFA) principles across internal and outsourced operations.
• Implement and monitor KPIs related to OEE, yield, cycle time, and process capability (Cp/Cpk).
• Ensure all manufacturing processes comply with FDA QSR, ISO 13485, and relevant product-specific regulations (e.g., IEC 60601, ISO 14971).
  
  

Capital & Project Management

• Lead automation and equipment capital projects from concept to installation and validation.
• Manage vendors, timelines, and budgets to ensure efficient project delivery and regulatory alignment.
  
  

Other

• Develop processes to promote cross functional teamwork and the best use of existing competencies.
• Responsible for developing talent in direct reports.
• Responsible for managing and resolving conflicts involving direct reports.
• Responsible for achieving the goals of Ambu as a whole.
• Facilitates regular communication and meetings with direct reports.
• Responsible for ensuring information is communicated to direct reports and the rest of the organization when necessary.
• Responsible for creating the yearly departmental budget and reviewing with the next level up of leadership.
• All other duties as assigned.
  
  

Qualifications

• Bachelor’s degree in related field and 10 years of relevant work experience
• Five years’ experience in management
• Five years’ experience working in the medical device field
• Must be able to speak, read, write and understand English
• Bilingual in Spanish is preferred
• Experience in automation and data-centric manufacturing environments.
• Strong background in medical device process validation, and regulatory compliance.
• Ability to complete complex reports and correspondence.