Manufacturing Engineer III; Onsite

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.

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.

• 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

• 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 Solid Works, Minitab, and project management tools