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 Responsibilities
Assemble 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 areas
Required Qualifications
1-3 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 required
Physical & Cleanroom Requirements
Must 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 assistance
Soft Skills & Expectations
Strong 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
Benefits: Health care insurance benefits available first of the month following 60 days of employment. Thirty (30) hours worked per week must be averaged in order to maintain coverage. 401k enrollment is available per the Secure Act guidelines. Earned Sick and Safe time is accrued and can be used per the State of MN guidelines. #IND345
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