Manufacturing Mechanical Engineer

Dentsply Sirona, Inc•West Manchester Township, PA

34d•$90,000 - $100,000

About The Position

The Manufacturing Mechanical Engineer identifies opportunities for improvement, maintains manufacturing and product quality, designs products and processes, and helps ensure cost-efficiency and compliance with regulatory standards. The role maintains, troubleshoots, and repairs electro-mechanical components and automation control systems. It supports manufacturing documentation, employee training, equipment and control-system design, production troubleshooting, continuous improvement, and transfers of new products into production. The position works with cross-functional project teams and Research and Development contacts to develop manufacturing processes and equipment that meet product-volume, quality, performance, safety, delivery, inventory, and cost expectations. It also supports process validation, employee training, investigations, and cost-improvement work. The posting describes three experience tiers: Manufacturing Engineer I, II, and III.

Requirements

Associate’s or bachelor’s degree in Mechanical Engineering, Electro Mechanical Engineering, or a related field.
Manufacturing Engineer I: 0–3+ years of plant engineering experience in a manufacturing environment preferred.
Manufacturing Engineer II: 3–6+ years of plant engineering experience in a manufacturing environment preferred.
Manufacturing Engineer III: 6+ years of plant engineering experience in a regulated manufacturing environment preferred.
Experience in electro-mechanical product assembly, with a demonstrable background in problem solving, debugging, root cause analysis, and corrective action.
Strong computer skills, including Microsoft Office Suite (Word, Excel, Access, and PowerPoint), email, and Internet.
Excellent written and verbal communication skills.
Interpersonal skills and a customer-focused orientation with internal and external customers.
Strong decision-making skills and ability to work independently with minimal supervision.
Comprehensive organization and analytical skills.

Nice To Haves

Professional certification in Six Sigma or Lean Manufacturing.
Experience in a regulated industry such as FDA-regulated, ISO, or medical-device manufacturing.
Experience with continuous-improvement teams and lean manufacturing.
Project-management experience.
General to proficient drafting skills with 3-D modeling software such as SolidWorks.
Manufacturing process validation experience.
Previous supervisory or management experience.

Responsibilities

Create, implement, modify, and monitor manufacturing procedures, testing and rework protocols, and process validations; help write SOPs to meet regulatory guidelines such as cGMP and ISO.
Train employees in production methods and processes, and document training to support adherence to proper manufacturing methods.
Assist with creating and revising Job Safety Analyses (JSAs).
Provide technical support and interpret data to support decisions and risk-benefit analyses, using controlled experimentation as needed.
Initiate or provide relevant information for manufacturing-related Corrective Action Requests (CARs).
Participate in and provide technical leadership for consumer complaint diagnosis and resolution, including documenting, logging, maintaining, and initiating investigations as needed.
Create operation drawings and process instructions and initiate engineering changes as needed.
Design fixtures and assembly methods as needed, and design or coordinate the design of mechanical fixtures, presses, and manually operated production equipment.
Define and document control-system requirements for equipment designs, and design control systems for new plant equipment or modifications to existing equipment.
Work with cross-functional project teams to develop process requirements and ensure equipment meets expected product-volume, quality, and performance needs.
Ensure in-house and contractor designs are adequately documented and that documentation is available for maintenance, redesign, and training.
Troubleshoot control-system malfunctions on production machines and plant equipment and recommend corrections or modifications.
Create original designs for moderately to highly complex mechanical parts and assemblies; complete geometric tolerancing analyses and present findings to engineering staff.
Troubleshoot production-line assembly and testing problems and resolve them using continuous-improvement and root-cause-analysis tools, including the A3 process.
Audit production-line methods through daily GEMBA walks and rebalance, retrain, or document methods as appropriate.
Participate in implementing and monitoring statistical process control, including control-chart development and identifying needed support tooling or equipment.
Select production equipment and design tools, fixtures, and gauges to improve costs, quality, and production scheduling.
Lead or support continuous-improvement projects; own non-conformances and corrective and preventive actions requiring higher-level technical investigation and resolution.
Own or engage with site- and company-level Operational Excellence tools and ongoing learning in continuous-improvement methods such as Spaghetti Diagrams, 5S, root cause analysis, and production flow.
Own or engage in site-specific employee-engagement processes such as On The Spot and Fix It Ticket.
Work with the designated Research and Development contact on new-product transfers to production, including manufacturing-area setup, process validation support, and employee training.
Develop safe, high-quality, cost-effective, and flexible production layouts and methods for new products.
Provide cost analyses of alternatives for addressing issues and implementing process-improvement projects.
Perform other duties as assigned.