Assembler II

The Assembler II is responsible for supporting medical device manufacturing within a cleanroom environment. This role includes precise assembly, inspection, testing, and packaging activities while following strict SOPs, GMP, and FDA guidelines. The ideal candidate has previous cleanroom experience, strong microscope skills, and the ability to work across multiple workstations through extensive cross-training.Key ResponsibilitiesAssemble medical device components with a high level of accuracy and attention to detailOperate within a certified cleanroom environment while adhering to SOPs, GMP, and FDA regulationsPerform regular microscopic inspection and microscope-assisted assembly (required skill)Conduct product inspections, functional testing, packaging, labeling, and boxingRotate between various workstations and maintain flexibility for cross-training across departmentsFollow all quality standards, documentation requirements, and detailed procedural instructionsStand for extended periods and lift up to 25 lbs as neededArrive on time and follow assigned shift schedules consistentlyUse production tools including electrical torque drivers and manual screwdriversSuccessfully complete multi-week training across multiple production areasRequired Qualifications1-3 years of experience working in a cleanroom environmentDemonstrated experience using microscopes for inspection and/or assemblyPrior medical device assembly experience strongly preferredAbility to read, write, and communicate effectively in EnglishFamiliarity with SOPs, GMP practices, and FDA guidelines is preferredHigh School Diploma or GED requiredPhysical & Cleanroom RequirementsMust comply with daily cleanroom gowning procedures (hair net, beard net if applicable, shoe covers, safety glasses)Ability to stand for long periods throughout the shiftAbility to lift up to 25 lbs without assistanceSoft Skills & ExpectationsStrong reliability and consistent punctualityFlexible and willing to rotate between multiple work areasAbility to learn new processes and follow detailed instructionsAdaptable to changing priorities and workstation needs