Job Description
Essential Duties And Responsibilities Ensures calibration system is always up to date and conforms to QMS policy. This includes bringing in new equipment and disposing of old equipment. Provides assistance to the manufacturing floor through inspection and training to ensure quality and delivery timelines are met. Provides QMS training to employees. Measures and tests engineering prototype catheters. Helps review and supplies test schemes for fixtures and devices. Evaluates design drawings and specifications for production and engineering products, dies and tools. Supports CIP activities. Supports Corrective and Preventative Actions (CAPA), Nonconforming Materials Reports (NCMR), Supplier Corrective Action Report (SCAR) activities and Failure Mode and Effects Analysis (FMEA). Reviews product documentation including drawings, test protocols, and technical reports. Perform and / or supervise testing, data collection and analysis through statistical software for research and prototype creation. Monitor the MN facility for compliance with the ATL QMS. Help ensure training records are up to date. Verifies production and engineering documentation through archiving. Works under general direction. Performs other duties and responsibilities as assigned. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required. Language Skills 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. Mathematical Skills 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. Reasoning Ability 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. Other Knowledge, Skills, And Abilities 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 software skills. Technical writing skills preferred. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Is occasionally required to stand; walk; reach with hands and arms; and lift up to 35 pounds. Is 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. Education & Experience Requirements A high school diploma or equivalent at a minimum, and 5+ years of experience on catheter manufacturing process development or equivalent combination of education and experience. Proficiency in Microsoft Office suite applications. Ability to work on multiple sustaining projects simultaneously. Understanding of ISO 13485:2016 requirements. What's In It For You Competitive salary and bonus compensation. Medical, Dental, Vision, and HSA plans. Life, AD&D, STD, LTD plans to help protect you and your loved ones. Generous 401k plan with Employer Match. Paid Holidays, PTO, and other leave programs to support your time off needs. What You Should Know About Us We believe there is a better way to bring medical devices to market. We use an engineer-to-engineer approach to develop custom interconnect solutions for medical devices that improve the quality of one's life'. Join us in our mission to be the leading provider of custom engineered solutions for top medical device manufacturers. ATL has operations in China, Costa Rica, Taiwan, UT-USA, MN-USA plus remote staff in strategic global locations ... and we're growing! Our Values Honesty Excellence Accountability Respect Teamwork