Manufacturing Engineer

Essential Duties and Responsibilities

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, In.

Metro, 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