Manufacturing Engineer

Job Summary

Develop, validate, document, maintain, and support processes, equipment, and process controls to assure that electro-mechanical products meet specifications and applicable regulations. Develop, implement, and manage value improvement projects which incorporate a Lean/Six-Sigma approach. Provide timely and effective development and implementation of manufacturing standards and process specifications to assure achievement of operations objectives. Implement production testing methods and procedures to assure that products meet specifications. Perform analyses on quality information to proactively improve potential problems and capture improvement opportunities.

Essential Functions

• Support new product development teams as manufacturing representative, ensuring a successful transfer of design into production.
• Evaluate new product designs to influence Design for Manufacturability, Design for Serviceability and Design for Cost by providing feedback to R&D during early phases of projects.
• Develop and improve process flows to ensure quality and production efficiency.
• Develop work plans as inputs to project schedules.
• Actively participate within a team to develop and improve the manufacturing processes for existing and new products.
• Develop and maintain robust Master Validation Plans for manufacturing processes.
• Create and execute IQ, OQ, PQ, TMV, Gage R&R protocols as required in the Master Validation Plan.
• Lead cross-functional team to create Process Failure Modes and Effects Analysis as part of internal risk management program.
• Lead implementation of sustaining changes at remote distribution and service facilities.
• Work closely with Operations groups, suppliers, and Quality Assurance to resolve in-house and supplier quality problems using established problem-solving methodologies.
• Support product transfers from outside vendors and other plants/facilities.
• Identify and support cost reduction projects to achieve goals.
• Define & implement specific solutions to technical problems, completing the tasks and writing reports that clearly document the results.
• Review & approve inspection plans, routers and product drawings.
• Identify sources of waste in production and implement changes that drive cost, quality and delivery.
• Identify and implement ergonomic improvements.

Required/Preferred Education and Experience

• Bachelor's Degree Manufacturing Engineering, Industrial engineering or a related discipline or equivalent required
• 4+ years of Operations Engineering experience in a manufacturing environment required

Knowledge, Skills and Abilities

• Demonstrated experience with supporting projects and effectively communicating project status.
• Experience with ISO quality systems and regulated manufacturing environments.
• Demonstrated use of risk management and quality tools such as failure modes and effects analysis and control plans.
• Ability to work as a team member within a cross-functional project team.
• Demonstrated proficiency in Lean and problem-solving tools with a high focus on process improvement.
• Experience in defining process requirements.
• Computer skills using Microsoft Office applications (Excel, Outlook, Teams, Word, PowerPoint). Microsoft Project, Minitab, Solidworks.