Manufacturing Engineer III — Medical Devices

Millar; Pearland (TX); On-site; USD 85,000 - 125,000; Full time

Job summary

Millar seeks a Manufacturing Engineer III to lead process improvement projects, validate equipment, and drive cost and quality performance in a medical device manufacturing setting. You will manage cross-functional activities with Product Development and OEM Engineering to bring new products to production.

The role emphasizes project leadership, root-cause analysis, and documentation, with strong collaboration across teams to comply with ISO 13485 and regulatory requirements, while delivering

Qualifications

• 7 years of manufacturing engineering experience.
• 5+ years in the Medical Device Industry.
• Experience leading engineering projects in a manufacturing environment.
• Strong understanding of manufacturing processes and equipment.
• Familiar with fabrication and assembly: adhesive bonding, soldering, machining, and electronic assembly.
• Experience drafting and executing validation protocols (IQ/OQ/PQ) and pFMEAs.
• Skilled in root cause analysis and corrective actions (CAPA).
• Excellent communication, organization and planning.

Responsibilities

• Project Management & Execution. Initiates, leads, and executes manufacturing process and equipment improvement projects.
• Develops, improves, documents existing and new processes, equipment, and fixtures.
• Leads and executes equipment and process validation, capital improvement project including equipment selection, justification and commissioning.
• Works closely with Product Development and OEM Engineering teams to efficiently and cost effectively introduce new products into Manufacturing.
• Lead investigations related to equipment failures, process deviations, quality issues, customer complaints, EERs, and CAPAs.
• Performs time studies, root cause analysis, trend analysis, process capability analysis (Cp/CpK), and data driven decision making to monitor and improve process performance.
• Utilizes problem solving methodologies such as fishbone diagrams, 5 why analysis, DMIAC etc.
• Provide technical leadership and training to operators and technicians.
• Periodically reports progress and status on projects and processes to management and stakeholders in oral or written manner.
• Prepares validation documents, engineering reports, procedures, work instructions, and technical presentations.
• Supports compliance with ISO 13485 quality management system requirements.
• Communicates with suppliers regarding component specifications, failures, and root cause analysis.

Skills

Project management

Root cause analysis

Data-driven decision making

Problem solving

Communication

Education

Bachelor's degree in engineering

Tools

SolidWorks

Minitab

Project management tools

Job description

Millar seeks a Manufacturing Engineer III to lead process improvement projects, validate equipment, and drive cost and quality performance in a medical device manufacturing setting. You will manage cross-functional activities with Product Development and OEM Engineering to bring new products to production.

The role emphasizes project leadership, root-cause analysis, and documentation, with strong collaboration across teams to comply with ISO 13485 and regulatory requirements, while delivering