Manufacturing Engineer

Essential Duties and Responsibilities

• Provides support to new business development relating to manufacturing matters as needed
• Identifies anticipated manufacturing, facility, environmental, and equipment needs
• Identifies known or possible manufacturing, health, safety and environmental risks
• Provides manufacturing cost estimates including labor, input on design (DFM) and required capital equipment
• Reviews program information/customer specifications including tooling requirements and design to understand product intent, functionality and test requirements
• Defines line labor, packaging and material supply requirements, as well as manufacturing lead times
• Drafts plans for manufacturing space and utility requirements
• Develops and maintains Process Flow Diagram and Control Plan
• Develops production line, work instructions and assists with training personnel
• Ensures all ISO procedures are followed within the work cell/production line
• Ensures GMP standards are followed at all times as required
• Executes validation protocols to support production lines as Required
• Affixes assist ADC/Tooling Engineers with tooling design review
• Performs incoming tool inspection (IQ) and drives tool corrections as necessary
• Ensures all equipment needed to manufacture is available, installed and qualified and if procurement is required, provides specifications
• Ensures that all equipment or process specifications and methodologies are documented
• Provides capacity and yield loss analysis
• Executes Installation Qualification(IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ) when required
• Conducts samplings and capability studies as required
• Provides continuous manufacturing engineering support through program end of life
• Seeks continuous improvements to optimize manufacturing operations by identifying opportunities to reduce production costs and to achieve gains in quality and productivity
• Provides recommendations/input with the design, building and implementation of new fixtures and tooling to support manufacturing operations
• Develops and maintain a preventative maintenance program for all tooling required to manufacture product
• Provides support to other departments to set and achieve program goals to maintain Total Customer Satisfaction
• Generates and maintains program-related documents including bill of material changes, process changes, updated work instructions, routings/travelers, nonconforming material reports and tooling damage reports
• Conducts meetings as needed to drive resolution of daily production and quality issues
• Supports QBRs with customers and provide/present manufacturing related matters
• Performs all assigned activity in a timely manner
• Works with co-workers and customers in a safe, professional, and cooperative manner

Qualifications

• Bachelor's degree (B. A.) in Mechanical, Industrial or Electrical Engineering required; plus at least 3-10 years related experience and/or training
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to write reports, business correspondence, and procedure manuals
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• To perform this job successfully, an individual should have knowledge of CAD Software, Word Processing software and Spreadsheet software as required