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Job Summary:

The Principal Manufacturing Engineer leads the design, development, implementation and validation of advanced manufacturing processes as well as changes to manufacturing processes for the purposes of quality improvement, manufacturing sustainability, cost improvement and new product introduction. Applies principles of mechanical design and automation while incorporating Six Sigma and Lean Manufacturing values to achieve organizational goals. Works closely across all business units to integrate and harmonize process equipment, processes, and associated infrastructure. Identifies and validates the required control process parameter based on best practices. Executes Engineering Studies, IQ, OQ and PQ protocol and reports for Equipment and processes.

Primary Responsibilities:

• Act as project leader for large-scale manufacturing projects to ensure manufacturing success through cross-functional collaboration with other business units, coordination of overall project and budget management.

• Ensure that production processes and systems as well as our product designs for both existing and new products produce the highest possible quality (consistency) and lowest possible cost.

• Responsible for driving multiple improvement programs through implementation and following-up on the results achieved, including Quality Monitoring and Actions, Production Efficiency, Improve Assembly Methods, Document and Implement Approved Changes.

• May be the project leader on Lean/Six Sigma initiatives and Cost Improvement Projects, 5S, Kaizen events.

• Constantly research for new materials, processing, testing and design techniques, which can be utilized to improve disposables quality, cost and manufacturability.

• Manage projects in compliance with Haemonetics SOPs by employing techniques such as project plans, product specifications, phase and design reviews, required documentation, test protocols and test reports.

• Provide necessary technical assistance for the business unit.

• Proactively identifies, communicates, and refers problems or coordination needs to leadership; provides timely detailed background/data to support problem-resolution; seeks guidance as necessary to respond to needs or changes, and quickly assesses requirements to meet target milestones, goals, and deadlines. Takes initiative to offer suggestions for improved methods, processes, products, services, or techniques.

• Translates engineering requirements, and design specifications into the manufacturing process. Interfaces with internal customers, suppliers, application users, and other technical and support personnel to support efforts.

• Provide technical leadership, trains, and mentors less-senior employees to support business initiatives and strategic goals, and evaluates or troubleshoots problems. Transfers knowledge/ technology solutions within or across groups.

• Proactively identifies and solves complex problems using specialized engineering principles, tools, data and methods to recognize and formulate problems, collect data through observation and experiment, and forms, tests, and validates hypotheses; efficiently selects and uses laboratory equipment and tools, and clearly documents, communicates, and summarizes technical findings and results for status updates, coordination, and remediation.

• Assists and supports Maintenance and manufacturing to troubleshoot production equipment.

• Executes Engineering Studies, IQ, OQ and PQ protocol and reports for equipment and processes.

• Ensures a safe work environment by complying with all company safety policies and procedures.

• Comply with all ISO 14001 requirements.

• Comply with internal environmental management system requirements, as applicable.

Qualifications:

Education

• Required bachelor's degree Engineering.

• Preferred bachelor's degree Mechanical, Plastics, or Biomedical Engineering.

• Preferred master's degree Engineering.

Experience

• For candidates with a bachelor's degree, minimum of 9+ years of experience within manufacturing, required.

• For candidates with a master's degree, minimum of 7+ years of experience within manufacturing, required.

• Professional experience in a highly regulated industry, required (i.e aerospace, nuclear, medical, etc.)

• Professional experience with blow molding and tooling design, including process design, required.

• Professional experience with IQ/OQ/PQ, preferred.

Skills

• Process Improvement

• Scrap Reduction

• COGs Reduction

• Machine Design

• Design for Manufacturability

• Microfluidics Manufacturing, Design and Application Experience

• Mechanical and Electrical Troubleshooting

• Root Cause Analysis

• Project Leadership

• Automation

Certifications

• Knowledge of Six Sigma/Lean methods

• Preferred Green Belt or Black Belt Certification

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