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Company Name : Osypka Medtec
Location : Longmont, CO 80504
Position : Production Technician II
Job Description : Production Technician 2This position is a part-time or full-time benefited non-exempt position inspecting, assembling and completing paperwork for a company that manufactures Class II and Class III medical devices and products in an ISO 13485 and 21CFR Part 820 environment.Organizational Competencies & Cultural Values: The mission of every employee at Osypka Medtec is dedicated to serving, supporting, and improving the lives of our patients and customers by adding value through innovative quality medical devices and services.This position supports the organizational principles which plans, promotes and embraces an attractive and high-quality living and working environment by facilitating ethical decisions for a growing organization. Our vision is to be a leading medical company in the development, production, sale, and marketing of permanent and temporary devices and services around the world. This position will be responsible to safely operate and maintain a variety of equipment related to production in a medical device manufacturing environment and to complete manual production functions to meet customer specifications.General Competencies: Work independently with minimal supervision and as part of a team.Perform basic calculations, equations, and analysis of engineering data.Make decisions exercising technical judgement and consult with an engineer, quality or supervisor on more difficult and unusual projects.Prepare reports under the supervision of engineer team.Complete necessary training and have the ability to follow Quality Management System.Establish and maintain effective working relationships with fellow employees, customers and suppliers.Maintain regular and punctual attendance.Ability to fluently read and write business related documents, including Quality records and other documents required by ISO13485:2016 and 21 CFR Part 820, in English language and to communicate fluently with internal employee, external customer, and auditors in the English language.Proficient in micro-laser welding and/or micro-resistance welding.All employees are expected to provide customer service, communicate in an effective manner both verbally and in writing, display professionalism and integrity, as well as work efficiently, effectively and accurately. Employees should take initiative, solve problems, display good judgment, and take ownership for delivering a high-quality product or service.Essential Job Functions: Build, test and assemble components and products and completion of paperwork.Proficient in the use of advanced assembly equipment such as laser welders, glove box laser welders, cross-sectioning equipment, microscopes, ultrasonic welders, robots, dispensers etc.Performs and conducts inspection of incoming, in-process and finished goods product.Review and provide completion of Device History Records and other inspection records.Provide feedback to manufacturing team on quality, protocol and data collected, including documentation of non-conformances as required.Ensure adequate identification and segregation of nonconforming materials and other consumables, materials and parts in inventory.Performs troubleshooting on production equipment as required.Performs preventative maintenance on production equipment as required.Rotates through workstations as needed for coverage, relief, and training purposes as required in conjunction with on-the-job trainingInterface with customers, clients and auditors as required during project meetings, inspections and acceptance testing.Keeps quality records current and accurately follows quality system protocol for documentation.Ability to work from and follow work instructions, engineering drawings and schematics, sketches and/or marked up drawings and prints.Ability to use creativity, initiative and experience to fill in gaps and/or to build on existing documentation to create solutions that work for the application.Work with Operations and Quality to maintain measuring and test equipment within the calibration system, including calibration database and records.Ability to learn new things quickly, work as part of a team and has a high level of initiative.Ability to recognize what needs to be done and will work with the team and manufacturing leadership to accomplish necessary tasks.Committed to continuous improvement, safety and ethical decision making.Writes, updates, and recommends updates to work instruction, standard operating procedures, and other manufacturing related documentation with consultation from Engineering.Support action plans to achieve short and long-range efficiency goals, selection of new production methods, designs of production fixtures and methods to monitor efficiencies, including documents such as PFMEAs and FMEAs as required.Ensure information and documentation is consistently accurate.Develop, support and ensure ongoing process and equipment recommendations to management and engineering team with equipment reviews and plans for implementation. Handle equipment logs and maintenance, including cleanroom.Demonstrate organizational skills, with the ability to handle and prioritize multiple projects simultaneously in a timely manner in a fast-paced environment.Maintain safe and clean working environment by following procedures, rules, and regulations.Supervisory Responsibilities: None.Education and Experience: Minimum of a high school diploma or equivalent with 3-5 years of directly related experience, or an Associate’s degree in electronics, automated systems, or related field or equivalent experience of 2 years or more in an assembly or inspection type operation for manufacturing preferred.Knowledge of a Quality System, FDA or ISO 13485:2016 standards a plus.Technical understanding of documentation, safety and design application required.Must have good verbal and written communication skills as well as computer skills.Possess an interest in and an aptitude for mechanics preferred.Experience with a cleanroom environment preferred.Experience working with manufacturing based technology processes and principles preferred.Physical Demands: Ability to sit or stand for long periods of time.Ability to lift, bend or move up to 40 pounds.Ability to use inspection equipment, including microscopes.Ability to work in a cleanroom environment.Compensation: Pay Range; $18.00 to $32.00 per hour depending on experienceNon-Exempt, Full-TimePaid Vacation per company policy in effect at hire date.Paid Holidays per company policy in effect at hire date.Paid Sick Leave per company policy in effect at hire date.Partial Payment by Company of Group Health Insurance401(k) with limited company matchingJob Type: Full-timePay: $18.00 – $32.00 per hourBenefits:401(k)Health insurancePaid time offSchedule:8 hour shiftMonday to FridayAbility to commute/relocate:Longmont, CO 80504: Reliably commute or planning to relocate before starting work (Required)Education:High school or equivalent (Preferred)Work Location: One location
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