Route 92 Medical
Assembler 2
Route 92 Medical, West Jordan, Utah, United States, 84088
PURPOSE OF JOB:Manufacturing operations cross functional support, focus on manufacturing key performance metrics.Line setup, training, production assembly, coating operations, engineering runs, and material handling.RESPONSIBILITIES:
Uses hand tools, fixtures and equipment to assemble and test products per Manufacturing Process Instructions (MPI), Work Instructions, and Standard Test Methods (STM)Accurately documents record of work on Lot History Record (LHR) and manufacturing formsSets up and maintains workstation; adheres to CER (Controlled Environment Room) requirementsOperates production equipment such as hot box, laminator and coil winderPerforms visual inspection and uses basic measuring tools such as caliper and snap gageIdentifies units that are non-conforming and notifies managementProvides feedback to management and engineers regarding process and product improvementsProblem Solve manufacturing related issues in a team environmentOperate manufacturing equipment in compliance with Calibration and Preventive Maintenance requirements. Support Equipment maintenance and qualifications, as neededOther duties as assigned; available to work overtime as requestedREQUIRED EDUCATION AND SKILLS:
High school diploma or equivalentAbility to read and speak English (i.e., read and understand manufacturing procedures)Experience and knowledge of GDP and GMP practices and ISO 13485 regulatory requirementsEffective communication, interpersonal and team skillsExcellent attention to detail and organizationBasic understanding of Lean Manufacturing concepts (Flow, 5S, Line Balance)PREFERRED EXPERIENCE:
Minimum of 2 years of experience in medical device manufacturing.Understanding of commonly used concepts, practices and procedures within the medical device industry.Ability to use microscopes, tweezers, razor blades, pliers and other handheld tools for small parts.Experience with catheter production equipment such as hot box, adhesive dispenser/cure, laminator, coil winder, and pouch sealers, etc.
Uses hand tools, fixtures and equipment to assemble and test products per Manufacturing Process Instructions (MPI), Work Instructions, and Standard Test Methods (STM)Accurately documents record of work on Lot History Record (LHR) and manufacturing formsSets up and maintains workstation; adheres to CER (Controlled Environment Room) requirementsOperates production equipment such as hot box, laminator and coil winderPerforms visual inspection and uses basic measuring tools such as caliper and snap gageIdentifies units that are non-conforming and notifies managementProvides feedback to management and engineers regarding process and product improvementsProblem Solve manufacturing related issues in a team environmentOperate manufacturing equipment in compliance with Calibration and Preventive Maintenance requirements. Support Equipment maintenance and qualifications, as neededOther duties as assigned; available to work overtime as requestedREQUIRED EDUCATION AND SKILLS:
High school diploma or equivalentAbility to read and speak English (i.e., read and understand manufacturing procedures)Experience and knowledge of GDP and GMP practices and ISO 13485 regulatory requirementsEffective communication, interpersonal and team skillsExcellent attention to detail and organizationBasic understanding of Lean Manufacturing concepts (Flow, 5S, Line Balance)PREFERRED EXPERIENCE:
Minimum of 2 years of experience in medical device manufacturing.Understanding of commonly used concepts, practices and procedures within the medical device industry.Ability to use microscopes, tweezers, razor blades, pliers and other handheld tools for small parts.Experience with catheter production equipment such as hot box, adhesive dispenser/cure, laminator, coil winder, and pouch sealers, etc.