Manufacturing Engineer

Essential Duties and Responsibilities

include the following:

• Designs, specifies and implements manufacturing processes, layouts, equipment and facility (incl. environmental, regulatory and utility) requirements;
• Develops test equipment and test processes;
• Develops, maintains and controls manufacturing support software;
• Supports manufacturing operations (safety, people, quality and cost);
• Supports Applications Development Center (ADC) with tooling design;
• Writes specifications and requests for quotations (RFQ) for equipment and facilities;
• Performs design review and final acceptance (FAT) of equipment & software;
• Writes and releases manufacturing documentation (e.g. ECO's);
• Acquires equipment documentation (manual, part list, etc.);
• Identifies continuous manufacturing improvements and cost reductions;
• Creates and maintains a clean and safe work environment;
• Develops manufacturing metrics (labor rates, costs, takt time, cycle time, value-add, etc.);
• Develops effective packaging;
• Supports production cost checks;
• Creates process flow diagrams;
• Creates control plans;
• Performs risk analyses (e.g. pFMEA, etc.);
• Creates and maintains work instructions and routing/travelers;
• Creates and maintains bill of material (BOM);
• Creates and maintains training matrices for manufacturing personnel;
• Trains manufacturing personnel;
• Implements and supports Lean manufacturing;
• Develops and executes Design of Experiments (DOE);
• Supports mold samplings;
• Develops and performs capability studies;
• Develops preventative maintenance requirements equipment and facilities;
• Supports MRP and production control systems;
• Supports inventory auditing;
• Supports calibration requirements, gage tracking and disposition;
• Supports new and existing business development (e.g. quoting, customer visits, etc.);
• Supports customer product development and prototype;
• Participates in DFM efforts with customer;
• Estimates manufacturing cost and delivery for labor, equipment and facilities;
• Supports Total Customer Satisfaction (TCS);
• Supports quarterly business reviews (QBR's);
• Provides technical leadership to all departments;
• Identifies and mitigates manufacturing, health, safety and environmental risks;
• Initiates and processes problem reports (e.g. NPMR, NMR, TD, tooling damage reports, etc.);
• Uses statistical methods;
• Uses structured problem solving (e.g. root cause analysis, 8D, 5 Why, 6 Sigma, etc.);
• Performs capacity and yield analyses;
• Ensures compliance with national, international, state and local governmental regulations and external regulatory registrars like UL, FDA, CSA, InMetro, TUV, etc.
• Ensures production compliance with GMP and ISO standards;
• Supports internal and external quality system audits;
• Performs validation (IQ, OQ, PQ) of processes, equipment, facilities and software;
• Maintains flexible and positive outlook;
• Maintains ISO training compliance;
• Works independently with effective time management;
• Produces accurate and reliable results;
• Travels occasionally (domestic and international);
• May supervise personnel;
• Mentors and trains associate engineers, manufacturing specialists and electro-mechanical technicians and manufacturing team members;
• Performs other duties as assigned;

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Education/Experience (must meet at least one of the following criteria):

• Bachelor's Degree (B.S.) in Mechanical, Electrical, Industrial, Chemical, Bio-Medical or Manufacturing Engineering from an accredited school or university;

• Three or more years job-related experience preferred;

• Or Bachelor's Degree (B.S.) in Science (e.g. Physics, Math, Statistics, Chemistry, or Biology);

• Three or more years job-related experience preferred