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