Senior Engineering Manager, Medical Devices & Systems

Otsuka ICU Medical; Austin (TX); On-site; USD 140,000 - 190,000; Full time

Job summary

Otsuka ICU Medical seeks a Senior Manager of Engineering to lead a team developing, supporting, and maintaining medical device instruments in an FDA-regulated manufacturing environment.

You will drive complex projects from planning to production readiness, coordinate cross-functionally, and mentor engineers to ensure high-quality deliverables and continuous improvement in manufacturing processes.

Qualifications

• Translates customer/product requirements into system designs.
• Requires strong cross-functional coordination and stakeholder communication.
• Hands-on skills in complex system design, integration, testing, and troubleshooting.
• Familiar with quality mgmt systems, risk assessment, and corrective actions.
• PM leadership with R&D, Product Management, and Process Engineering collaboration.
• Six Sigma Black Belt and Lean Manufacturing experience desired.
• Experience in medical device development is preferred.
• Analytical/problem-solving skills for mechanical systems.

Responsibilities

• Lead complex engineering projects from planning through production readiness.
• Report status and issues to Project Review Board.
• Drive root-cause analyses and CAPAs for complaints and defects.
• Ensure timely closure of site corrective actions.
• Collaborate with R&D, Marketing, QA/QC, Regulatory, and Operations.
• Prioritize deliverables with resource planning.
• Identify and mitigate program risks with contingency plans.
• Provide technical leadership and mentor engineers.

Skills

Project management

Cross-functional leadership

Medical device development

Root cause analysis

Regulatory knowledge

Process improvement

ERP systems

Six Sigma Black Belt

Education

Bachelor's degree in Engineering

Black Belt certification

Tools

AutoCAD

ERP systems (Oracle)

Microsoft Office

Job description

Otsuka ICU Medical seeks a Senior Manager of Engineering to lead a team developing, supporting, and maintaining medical device instruments in an FDA-regulated manufacturing environment.

You will drive complex projects from planning to production readiness, coordinate cross-functionally, and mentor engineers to ensure high-quality deliverables and continuous improvement in manufacturing processes.