Manufacturing Engineering III

Manufacturing Engineering III

The Manufacturing Engineer III provides technical leadership and engineering support for catheter manufacturing operations, quality compliance, and continuous improvement initiatives. This role partners with cross-functional teams to resolve product and process issues, lead investigations, support validation and qualification activities, and drive improvements in safety, quality, delivery, and cost. The Manufacturing Engineer III is responsible for maintaining compliant documentation, supporting design control activities, applying risk management methodologies, and leading engineering projects that enhance manufacturing performance and operational efficiency.

Principal Responsibilities:

• Monitor, analyze, and improve manufacturing performance metrics, including yield, efficiency, throughput, quality, and scrap.
• Lead investigations and resolution activities related to nonconformances, complaints, CAPAs, and manufacturing process issues, serving as a technical lead or key contributor as required.
• Drive engineering actions identified through daily management and visual management processes.
• Lead continuous improvement initiatives focused on reducing waste, increasing productivity, improving quality, and enhancing process and operator efficiency using Lean and Six Sigma methodologies.
• Develop, revise, and maintain manufacturing and engineering documentation, including work instructions, SOPs, specifications, protocols, and engineering drawings; provide training as required.
• Plan, author, execute, and document engineering studies, process qualifications, validations, and test method validations (IQ, OQ, PQ, TMV) in compliance with FDA, ISO, and company requirements.
• Partner with R&D to support new product introductions, process development, and design transfer activities, ensuring manufacturability, quality, and cost-effectiveness.
• Lead engineering projects from concept through implementation, including scope definition, resource planning, timeline management, risk assessment, execution, and results measurement.
• Collaborate with Operations leadership to identify and implement technical solutions that support safety, quality, capacity, and production objectives.
• Provide technical leadership, coaching, and mentorship to Manufacturing Technicians, junior Engineers, and cross-functional teams.
• Support audits, inspections, and regulatory compliance activities as needed.
• Perform additional duties and special projects as assigned.

Education / Experience Requirements:

• Bachelor's degree in Engineering or a related technical discipline required;
  Master's degree preferred.
• Minimum of 5 years of manufacturing engineering experience with a Bachelor's degree, or 3 years of relevant experience with a Master's degree.
• Experience supporting manufacturing operations in a regulated industry; medical device manufacturing experience preferred.
• Experience leading engineering projects and collaborating effectively within cross-functional teams.
• Experience managing project portfolios, strategic initiatives, or PMO-related activities preferred.
• Demonstrated application of engineering, analytical, project management, and continuous improvement methodologies preferred.
• Lean Practitioner, Six Sigma, PMP, or related professional certifications preferred.

Specialized Skills / Other Requirements:

• Experience with process validation and qualification activities, including IQ, OQ, PQ, PFMEA, and DFMEA.
• Knowledge of FDA Quality System Regulations (QSR), ISO 13485, and applicable medical device manufacturing requirements preferred.
• Experience with production test fixture design and development preferred.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Experience with SAP, Agile, or similar business systems preferred.
• Knowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologies preferred.
• Strong analytical, troubleshooting, and problem-solving skills with the ability to make data-driven decisions.
• Excellent written, verbal, organizational, and interpersonal communication skills.
• Ability to manage multiple priorities and execute projects with minimal supervision.
• A…