METHODS ENG

JOB SUMMARY:

Performs entry level professional methods engineering work for Structure Medical, LLC. Creates Inspection Plans to support the Process Failure Mode and Effects Analysis (PFMEA) and Control Plans developed by senior members of Methods Engineering. Work is performed under general supervision with minimal latitude for the use of initiative and independent judgment based on professional education and previous experience.

EXAMPLES OF ESSENTIAL FUNCTIONS:

The list of essential functions, as outlined herein, is intended to be representative of the tasks performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

• Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators
• Creates ballooned drawings and inspection sheets, in-process models and drawings, Vision System inspection programs, rework travelers, and overlays (Mylar and digital) for comparators
• Designs custom gages and fixtures for production and inspection
• Designs document templates
• Diagnoses failures of defective products
• Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors
• Assures product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes
• Trains machining operators on the proper usage of inspection equipment, custom gages, inspection programs, and overlays
• Reviews design and requirements of customer products; relays related information to program management and customers
• Uses training, experience and judgment to translate general objective statements into plans, processes, and documents to define and control manufacturing processes
• Provides or coordinates staff training
• Assists the Material Review Board, as necessary

MINIMUM QUALIFICATIONS:

High school diploma, GED or technical certificate; bachelor’s degree in engineering technology or related field preferred; supplemented by some engineering experience in a manufacturing environment; or an equivalent combination of education, certification, training, and/or experience.

KNOWLEDGE, SKILLS, AND ABILITIES:

• General knowledge of the operation and programming of CMM’s/Vision Systems
• Knowledge and understanding of ISO 13485 and FDA 21CFR820 as it pertains to the job
• Knowledge of and ability to use standard gaging (micrometers, calipers, pins, etc.)
• Knowledge of proper documentation procedures
• Skilled in the use of computer software including but not limited to Microsoft Outlook, Word, and Excel, SolidWorks software, and Enterprise Resource Planning (ERP) systems
• Skilled in setting priorities that move projects through efficiently to achieve customer and quality objectives
• Skilled in working independently and following through with assignments with minimal direction
• Ability to use or learn proper documentation procedures
• Ability to use analytical thinking skills to develop and measure processes
• Ability to read blueprints
• Ability to use sine plates to make measurements with accuracy
• Ability to create Technical Document Packages (TDP’s), ballooned drawings, and inspection sheets
• Ability to apply knowledge of inspection methods and geometric dimensioning and tolerancing to create custom gaging
• Ability to use reasoning skills that minimize duplication of efforts, including but not limited to comparing, classifying, analyzing and coordinating
• Ability to use critical thinking skills to solve problems and suggest improvements to processes
• Ability to consistently exercise discretion and independent judgment in the performance of the job
• Ability to multi-task while working with tight deadlines and shifting priorities
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
• Ability to learn and adapt to changing technology
• Ability to clearly communicate and understand information in English, both orally and in writing

Skills

• Visual
• ISO 13485