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 Responsibilities

• Assemble medical device components with a high level of accuracy and attention to detail
• Operate within a certified cleanroom environment while adhering to SOPs, GMP, and FDA regulations
• Perform regular microscopic inspection and microscope-assisted assembly (required skill)
• Conduct product inspections, functional testing, packaging, labeling, and boxing
• Rotate between various workstations and maintain flexibility for cross-training across departments
• Follow all quality standards, documentation requirements, and detailed procedural instructions
• Stand for extended periods and lift up to 25 lbs as needed
• Arrive on time and follow assigned shift schedules consistently
• Use production tools including electrical torque drivers and manual screwdrivers
• Successfully complete multi-week training across multiple production areas

Required Qualifications

• 13 years of experience working in a cleanroom environment
• Demonstrated experience using microscopes for inspection and/or assembly
• Prior medical device assembly experience strongly preferred
• Ability to read, write, and communicate effectively in English
• Familiarity with SOPs, GMP practices, and FDA guidelines is preferred
• High 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 shift
• Ability to lift up to 25 lbs without assistance

Soft Skills & Expectations

• Strong reliability and consistent punctuality
• Flexible and willing to rotate between multiple work areas
• Ability to learn new processes and follow detailed instructions
• Adaptable 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