Manufacturing Engineer

About the role

This key role reports to the Engineering Manager and is responsible for developing, introducing, and improving highly capable manufacturing processes to produce components for medical instruments and aerospace applications. Scope includes machining, molding, assembly, finishing, and packaging operations.

Responsibilities

• Develops and implements optimized, highly capable, and cost-effective manufacturing processes and inspection methods in accordance with product specifications and quality standards.
• Recommends and implements improvements to production processes, assembly methods, and controls using Lean Manufacturing and Six Sigma tools.
• Collaborates with Quality Engineering for product tooling, gauging, and fixtures design to ensure robust production methods, achieving zero defects, reducing cost of poor quality, and implementing standard work.
• Supports creation of PFMEAs and control plans.
• Estimates resource requirements, production times, and relative costs to provide data for operational decision-making.
• Documents and qualifies manufacturing and inspection methods.
• Assists with justifications for capital expenditures.
• Works closely with manufacturing departments to develop, coordinate, and implement technical training for employees.
• Provides engineering support to the production department to troubleshoot and resolve technical problems, ensuring on-time delivery to customers and improving productivity.
• Leads Root Cause Analysis for non-conformances and Corrective Actions (CAPA).
• Leads IQ/OQ/PQ and other process validation activities.
• Leads projects for Lean Initiatives.
• Performs other related duties as assigned.

Requirements

• Bachelor’s degree in Industrial Engineering or related Engineering field, or Manufacturing.
• Minimum 3 years’ experience in a manufacturing machining environment, preferably in sheet metal fabrication or plastic environment, as well as assembly using state-of-art manufacturing processes including cellular manufacturing and Demand Flow Technology, or equivalent combination of education and experience.

Skills

• Demonstrated engineering experience in a high-precision machine shop and/or assembly environment.
• Experience in medical devices manufacturing is highly preferred.
• Proficiency in the use of Mastercam, SolidWorks, CREO/ProE, or other CAD/CAM software.
• Knowledge of blueprint reading and GD&T required.
• Ability to develop CNC programs desired.
• Secondary process experience (welding, polishing, electro-polish, passivation, assembly) desired.
• Experience in fixture design and tooling selection.
• Strong statistical analysis background preferred.
• Highly knowledgeable of Lean techniques and Six Sigma tools; Green Belt certification is a plus.
• Technical skills in manufacturing processes and methods including flow, layout, and production equipment.
• Effective at planning, prioritizing, and organizing own work and activities.
• Experience with quality control systems and documentation.
• Excellent communication skills and self-motivated.
• Team player with an entrepreneurial attitude.
• Problem-solving and root cause analysis experience.

Work Environment

The role involves a manufacturing environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

• May be required to stand, walk, use hands to finger, handle, or feel, reach with hands and arms, talk, or hear.
• May be required to sit, climb or balance, stoop, kneel, crouch, or crawl.
• May occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required include close vision, distance vision, peripheral vision, and ability to adjust focus.