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

Employment type
Full-Time

Work arrangement
No