Manufacturing Engineer III (Onsite)

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

Come be a part of a dynamic team that is helping to make the improbable possible through innovation, customer relationships and support of our novel catheter-based, pressure sensing and telemetry technology, which is utilized worldwide in medical research, diagnostics and clinical treatment.

Millar works directly with customers and business partners to help push medical discovery to the next level. From mouse to man, our company plays an important role in medical discovery at every level. Join Millar during an exciting period of growth, as we take the opportunity to expand our clinical and research markets and leave a lasting impact on the medical community.

Job Summary

The Manufacturing Engineer III position is responsible for leading and executing process improvement initiatives, equipment and manufacturing projects, validation activities, and complex problem-solving efforts. This role serves as a key technical resource within the organization, managing cross-functional projects, driving operational excellence, and supporting continuous improvement initiatives to improve processes, quality, equipment, delivery, and cost performance.

This role utilizes strong project management, root cause analysis, planning, communication, and validation expertise to lead engineering initiatives from concept through implementation while ensuring compliance with company and regulatory requirements.

Essential Responsibilities and Duties

• Project Management & Execution. Initiates, leads, and executes manufacturing process and equipment improvement projects
• Develops, improves, and 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
• Additional tasks and duties as assigned

Education, Experience, and Knowledge

• Bachelor’s degree in engineering (Manufacturing, Mechanical, Electrical, Industrial, or related field)
• 7 years of manufacturing engineering experience, with at least 5 years’ experience in the Medical Device Industry
• Experience leading engineering projects in a manufacturing environment
• Strong understanding of manufacturing processes and equipment
• Knowledgeable and familiar with a wide range of fabrication and assembly processes including adhesive bonding, soldering, machining soldering, and electronic assembly
• Experience with drafting and execution of validation protocols and reports (IQ, OQ, PQ,), pFMEAs, work instruction and component specification
• Skilled in root cause analysis and corrective action methodologies
• Excellent communication, organization, and planning skills
• Proficiency in SolidWorks, Minitab, and project management tools