Sr. Manufacturing Engineer

Overview

The Senior Manufacturing Engineer is a key contributor to the design and development of manufacturing processes, tools, and procedures. Provides direct engineering support for New Product Introduction (NPI), development of assembly & test processes, tools, and inspection methods. Identifies and leads and continuous improvement activities and projects. Responsible for manufacturing process verification & validation and employee training effectiveness. Ensures the smooth running of manufacturing processes with the highest possible quality and efficiency.

Principal Responsibilities

• Designs, develops and documents manufacturing systems, processes and tools for new products, product & process changes, to meet targets for quality, efficiency, and reliability.
• Creates and maintains manufacturing plans, procedures, process FMEAs, flowcharts, workflows, layouts, routings, time standards, and associated tools/equipment, fixtures, and material handling systems.
• Provides direct manufacturing engineering support for product characterization, and product builds at prototype, verification, validation, and commercial manufacturing stages, to meet ISO 13485 requirements & FDA regulations.
• Interfaces with design engineers during new product development or product enhancement projects to develop DMR documentation and assure design for manufacturability, assembly & test.
• Identifies/leads continuous improvement projects using Lean methodologies to improve manufacturing/business systems, processes, and tools to improve quality, eliminate waste, and reduce cost; fosters a Lean culture.
• Maintains manufacturing master data in ERP systems; initiates/approves engineering change requests/orders.
• Drives and supports the implementation of effective manufacturing process controls, statistical measurements, and metrics to assure products & processes meet quality and business objectives.
• Performs capacity and utilization studies, time and motion studies, labor/cycle time analysis, and line balancing.
• Represents manufacturing in all internal quality processes including MRB & non-conformance handling, complaint reviews, and internal and external quality audits; drives resolution of quality issues using CAPA systems.
• Functions as the lead technical liaison with suppliers and contract manufacturers; provides technical guidance to suppliers regarding compliance with engineering drawings and other technical requirements/specifications.
• Partners with quality engineering and suppliers to ensure corrective action or problem resolution to meet quality, cost and delivery targets, and support supplier performance management.
• Leads large scale projects related to facility moves, re-layouts, Lean training, and Lean transformation projects.
• Perform miscellaneous duties and projects as assigned and required.

Training, Skills, Knowledge and/or Experience

• 8+ years of related manufacturing/industrial engineering work experience required, including 3+ years of experience with medical devices in FDA QSR & ISO13485 regulated environment.
• Experience with manufacturing of complex electro-mechanical products required; some quality engineering experience and exposure to opto-mechanical/electrical product manufacturing preferred.
• Proven track record of creating FMEAs, performing process verification and validation, developing & validating test methods, and transferring new products into manufacturing.
• Lean and/or Six Sigma Black Belt certification highly preferred, with demonstrated success in rolling out Lean methods and tools to improve quality and efficiency in manufacturing environments.
• Microsoft Office 365 Suite & ERP/PLM proficiency required, with working knowledge with SolidWorks, Microsoft Visio, Microsoft Access, Microsoft Project, and electronic documentation systems.
• Demonstrated experience in data collection and statistical analysis, proficiency with Minitab or other statistical software highly preferred.
• Demonstrated understanding of mechanical dimensioning and tolerancing, interpretation of component specifications, Quality tools/methodologies, problem solving and root cause analysis, 5S and poka-yoke.

Education Requirements

Bachelor's degree in manufacturing, industrial engineering, or a related technical field; master's degree preferred. Master's degree preferred.

Competencies

• In-depth understanding of lean manufacturing and supply-chain management methods and tools.
• Strong attention to detail, with excellent analytical, problem-solving, and project management skills.
• Strong data collection & analysis, problem solving, presentation and communication skills.
• Adept at summarizing and presenting complex information to non-technical personnel.
• Ability to learn and utilize new knowledge quickly and effectively, work independently, without appreciable direction.

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