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Engineering – Non Degreed I
Job Summary:
Working under general supervision, this position is responsible for the production of high-quality medical device instruments. This position includes detailed assembly and testing of various electronic components and finished devices in a controlled manufacturing environment.
Job Responsibilities:
• Performs testing of electronic components and assemblies using automated test equipment
• May perform mechanical assembly of electromechanical subassemblies and devices
• Ability to read, comprehend and follow written procedures; understand and follow verbal instructions. May instruct others in the use of all manuals, test procedures and documentation associated with specialized equipment.
• Reads and interprets engineering drawings, schematics and complex test procedures.
• Participates in continuous improvement/quality initiatives in order to enhance production processes to 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 the quality of all products.
• 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 SOP’s, equipment, policies and procedures, including any department specific requirements.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Minimum Qualifications:
• Experience with electronic assembly and test in a medical device industry preferred.
• High School Diploma or equivalency is required, preferred AAS
• 2 or more years experience with electromechanical assemblies/electronic manufacturing, technical certifications, etc. preferred Preferred Qualifications:
• Experience in troubleshooting equipment, building and or testing of electronic assemblies
• Working knowledge of IPC standards and use of complex tools and equipment specific to functional areas
• Experience in GMP, ISO, and FDA controlled environments preferred
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance.
• Ability to work scheduled overtime as required is preferred.
• Ability to hand and lift up to 25 lbs. as needed for specific job functions
• Must be able to sit and/or stand for long periods of time.
• Ability to frequently sit, stand, walk, reach within hands and arm’s length, stoop, kneel and crouch.