Senior MS&T Process Engineer — GMP & Optimization

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 120,000 - 160,000; Full time

Job summary

Otsuka ICU Medical LLC is seeking an experienced engineer to lead advanced, complex projects with regulatory compliance. You will plan, integrate subsystems, and guide cross-functional teams while maintaining process reliability and partnering with manufacturing, engineering, and vendors. Strong project management and DOE expertise are required.

The role emphasizes independent work, potential team leadership, and collaboration across functions to drive efficiency and innovation in IV solutions.

Qualifications

• Bachelor’s degree in Mechanical, Chemical, Industrial, or Biomedical engineering.
• 7+ years’ experience with a bachelor’s degree or 5 years with a PhD in relevant field.
• Credentialing requirements to perform the essential function of your role at customer locations.

Responsibilities

• Analyzes, plans, organizes and completes projects of a very complex nature.
• Develops scope and provides creative solutions.
• Plans, organizes and conducts technical projects; integrates subsystems and components in total systems design.
• Develops specifications from customer requirements.
• Provides direct project management support including planning, securing funding, technical support to Validation Coordinator, and oversight to project support organizations.
• Implements GMP change control and validation processes.
• Previewing/providing feedback on project deliverables and remediation strategies.
• Collaborates with center functions on product development initiatives.

Skills

Advanced engineering

Project management

Cross-functional collaboration

DOE

Regulatory compliance

Education

Bachelor's degree

Master's or PhD preferred

Engineering specialty: Mechanical, Chemical, Industrial, Biomedical

Job description

Otsuka ICU Medical LLC is seeking an experienced engineer to lead advanced, complex projects with regulatory compliance. You will plan, integrate subsystems, and guide cross-functional teams while maintaining process reliability and partnering with manufacturing, engineering, and vendors. Strong project management and DOE expertise are required.

The role emphasizes independent work, potential team leadership, and collaboration across functions to drive efficiency and innovation in IV solutions.