Provides assistance to the manufacturing floor to ensure quality and delivery timelines are met.
Develops and supplies tooling, test schemes, fixtures, and devices.
Develop and evaluate design drawings and specifications for product, mechanical equipment, dies, tools, and controls using computer-assisted drafting CAD software.
Thinks critically to improve efficiency and turn-around time. Supports CIP activities.
Measures parts, creates prototypes, tests parts.
Supports Corrective and Preventative Actions (CAPA), Nonconforming Materials Reports (NCMR), Supplier Corrective Action Report (SCAR) activities and Failure Mode and Effects Analysis (FMEA).
Produces and reviews product documentation including drawings, test protocols, and technical reports.
Perform and/or supervise testing, data collection and analysis, research, and prototype creation.
3D CAD design and drawing support using SolidWorks.
Develop and design detailed specifications for components or machinery.
Works under general direction.
Performs other duties and responsibilities as assigned.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers.
Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Self-starter, organized, willingness to perform repeated similar activities. Willingness to provide input, eager to learn, ability to think outside the box. Ability to define problems, organize, evaluate, and collect data, establish facts, and draw valid conclusions. Possesses strong computer skills. Technical writing skills, machine shop skills, and prototyping skills preferred.
Occasionally required to stand; walk; reach with hands and arms; and lift up to 35 pounds. Frequently required to sit; use hands to finger, handle, or feel; and talk or hear. Has the ability to adjust the eye to bring an object into sharp focus. Works in moderate noise levels.
High school diploma or equivalent at a minimum, and 10+ years of experience on catheter manufacturing process development or equivalent combination of education and experience. Experience in CAD software using SolidWorks is a plus. Proficiency in Microsoft Office suite applications. Ability to work on multiple sustaining projects simultaneously. Experience in design of components for catheters. Understanding of ISO 13485:2016 requirements.