Manufacturing Engineer

Job Description

Salary: $75,000-$115,000 DOE

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. ECOs);

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 (QBRs);

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):

Bachelors 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 Bachelors Degree (B.S.) in Science (e.g. Physics, Math, Statistics, Chemistry, or Biology);

Three or more years job-related experience preferred

Full-time