Manufacturing Mechanical Engineer

As the Manufacturing Mechanical Engineer, you will be responsible for identifying areas for improvement, maintaining high levels of manufacturing and product quality, designing new products and processes, as well as ensuring cost-efficiency and conformance with all regulatory standards. This role must be able to maintain, troubleshoot, and repair electro-mechanical components, and automation control systems.

Essential Job Functions

• Create, implement, modify and monitor technical documentation such as manufacturing procedures, testing protocols, rework protocols and process validations that accurately reflect production methods, and assist in writing SOPs (Standard Operating Procedures) to meet all regulatory guidelines (cGMP, ISO, etc.)
• Train and instruct others in the methods and processes used to produce our products.  Provide and document training to ensure adherence to proper manufacturing methods.
• Assist in the creation and revision of all JSAs (Job Safety Analysis) as needed.
• Provide technical support and data interpretation to make informed, intelligent decisions with appropriate risk-benefits analysis, using controlled experimentation as needed.
• Initiate and/or supply necessary relevant information to manufacturing related CAR’s.
• Active participation and technical leadership for consumer complaint diagnosis and resolution, including reviewing, documenting, logging, maintaining and/or initiating the investigations as needed.
• Create operation drawings and processes instructions as well as initiating engineering changes as needed.
• May design fixtures and assembly methods.
• Designs and/or coordinates the design of, mechanical fixtures, presses, and manually operated production equipment.
• Defines and documents control system requirements for equipment design to meet all expectations including safety, quality, delivery, inventory and cost.
• Designs control systems for new plant equipment or modification of existing equipment taking into consideration cost, level of technology, available space, time limitations, company planning, and other technical and economic factors.
• Works closely with cross-functional project teams to develop process requirements ensuring equipment is designed to provide expected product volumes, quality, and performance.
• Ensures that all designs, whether designed in-house or by a contractor, are adequately documented and documentation is available for maintenance, redesign, and training.
• Troubleshoots control system malfunctions on production machines and plant equipment resulting in recommendations for corrections and/or modifications.
• Creates original design work of moderate to complex mechanical parts and assemblies. 
• Able to complete geometric tolerancing analysis and present findings to engineering staff
• All other duties as assigned.

Continuous Improvement:

• Troubleshoot problems within the various production lines related to assembly and testing processes and bring them to resolution using continuous improvement tools such as the A3 process and other root cause analysis tools.
• Audit production line methods supported with GEMBA walks completed daily, i.e. rebalance, retrain, or document accordingly.
• Actively participate in the implementation and monitoring of statistical process control techniques, including control chart development, application and identification of required support tooling or equipment.
• Select production equipment and tool/fixture/gage design to implement production cost improvements, ensure quality and meet production schedules.
• Lead/support process improvement efforts which include continuous improvement projects.
• Own NCs (Non-Conformances) and CAPAs (Corrective Action / Preventive Action) that require higher level technical skill to investigate and resolve.
• Own or engage with Operational Excellence tools at a Site level rolling up to Company level.
• Own or engage in sustained learning of Continuous Improvement with tools such as Spaghetti Diagram, 5S, Root Cause Analysis, Production Flow and others.
• Own or engage in various Site-specific Employee Engagement Processes such as: On The Spot, Fix It Ticket and others.

New Product Development

• Work with the designated Research and Development contact on New Product transfers to production, including setting up the manufacturing area, assisting with process validation and training employees.
• Develop layouts and methods to produce new products in a safe, high quality and cost-effective manner, and in such a way as to be flexible in meeting the Company’s volume requirements.
• Take an active role in providing cost analysis of various alternatives to issues, or process improvements in the implementation of identified cost improvement projects.

Education: 

• Associate’s or Bachelor’s Degree in Mechanical Engineering, Electro Mechanical Engineering or related field required.

Certifications/Licensing:

• Professional certification in Six Sigma or Lean Manufacturing a plus but not required.

Years and Type of Experience:

• Manufacturing Engineer I; 0–3+ years plant engineering experience in a manufacturing environment preferred.
• Manufacturing Engineer II; 3-6+ years plant engineering experience in a manufacturing environment preferred. 
• Manufacturing Engineer III; 6+ years plant engineering experience in regulated manufacturing environment preferred.  Previous supervisory or management experience a plus.

Key Required Skills, Knowledge and Capabilities:

• Experience in a regulated industry (FDA, ISO, medical device, etc.) helpful.
• Experience with continuous improvement teams, lean manufacturing, etc. preferred.
• Project management experience a plus.
• Strong computer skills with knowledge of Microsoft Office Suite (Word, Excel, Access and PowerPoint), e-mail and Internet.
• Excellent communication skills – written and verbal.
• Interpersonal skills to include customer-focused orientation with both internal and external customers.
• Strong decision-making skills, ability to work independently with minimal supervision.
• Comprehensive organization and analytical skills
• General to proficient drafting skills with 3-D modeling software such as SolidWorks preferred.
• Experience in electro-mechanical product assembly required with a demonstratable background in problem solving (debug, root cause analysis and corrective action).
• Manufacturing process validation experience a plus.