Operator IWorking under general supervision, this position is responsible for the production of high-quality medical device instruments, including detailed assembly and testing of various electronic components and finished devices in a controlled manufacturing environment.Key responsibilities include:Performs testing of electronic components and assemblies using automated test equipment.Documents findings of investigation in a readable, timely format.May perform mechanical assembly of electromechanical subassemblies and devices.Reads, comprehends, and follows written procedures; understands and follows verbal instructions. May instruct others in the use of manuals, test procedures, and documentation associated with specialized equipment.Reads and interprets engineering drawings, schematics, and complex test procedures.Participates in continuous improvement and quality initiatives to enhance production processes and achieve quality and profitability metrics.Maintains accurate records to ensure Device History Records and quality documents are accurate, all parts are traceable, and quality issues can be addressed to assure product quality.Prioritizes work by determining the sequencing and timing of different jobs based on precedence and importance.Positively represents the company during tours by demonstrating techniques and sharing appropriate information.Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Complies with U.S. Food and Drug Administration (FDA) regulations, ISO or other regulatory requirements, Company policies, operating procedures, processes, and task assignments.Adheres to all environmental, health and safety SOPs, equipment, policies and procedures, including any department-specific requirements.Maintains positive, cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.Minimum qualifications:High School Diploma or equivalency (required).2+ years of experience with electromechanical assemblies / electronic manufacturing; technical certifications preferred.Experience with electronic assembly and test in the medical device industry preferred.
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