Clean Room Assembly Technician
Level: Entry-Level to Mid-Senior Level
Location: Plymouth Township, MI
Department: Manufacturing / Production
Reports To: Production Supervisor or Manufacturing Engineer
Company Overview
Miller Technical Services (MTS) is a leading ISO 13485-certified and FDA-registered contract manufacturer serving the medical device and advanced manufacturing industries. Our team specializes in precision assembly, testing, and validation of Class I, II, and III devices — providing end-to-end support from concept through production. MTS is committed to innovation, quality, and safety in everything we produce.
Learn more at www.mtsmedicalmfg.com.
Position Summary
The Clean Room Assembly Technician is responsible for the precise assembly, inspection, and packaging of medical devices and subassemblies within a controlled ISO Class 8 cleanroom environment. This position plays a key role in ensuring products meet strict quality, cleanliness, and regulatory standards required for FDA and ISO 13485 compliance.
The technician will work as part of a collaborative production team performing assembly operations, in-process testing, line clearance, and documentation. This position requires strong attention to detail, manual dexterity, and the ability to follow written procedures and visual work instructions.
Primary Responsibilities
-
Perform manual and semi-automated assembly of disposable and reusable medical devices according to work instructions and drawings.
-
Conduct in-process testing and visual inspection to ensure quality conformance.
-
Perform line clearance, batch documentation, and labeling per FDA and ISO standards.
-
Support routine cleaning and environmental monitoring within the cleanroom area to maintain ISO Class 8 compliance.
-
Accurately complete all production paperwork, lot history records, and traceability documentation.
-
Assist in setup and teardown of assembly lines and production equipment.
-
Follow all Good Manufacturing Practices (GMPs) and cleanroom gowning procedures.
-
Participate in training, quality audits, and continuous improvement initiatives.
-
Report any nonconformances, safety issues, or equipment concerns to the supervisor promptly.
-
Support additional manufacturing activities as assigned, including packaging, labeling, or subassembly work outside the cleanroom when required.
Preferred Qualifications
-
Prior experience with cleanroom assembly or manufacturing in a regulated environment (medical device, pharmaceutical, aerospace, or electronics).
-
Familiarity with 21 CFR Part 820 (FDA Quality System Regulation) and ISO 13485 requirements.
-
Experience with microscopic assembly, small parts handling, or device testing a plus.
-
Ability to read and interpret technical drawings, blueprints, and standard operating procedures (SOPs).
-
Excellent hand–eye coordination, fine motor skills, and focus on precision and consistency.
-
Strong organizational, teamwork, and communication skills.
-
Comfortable wearing required cleanroom attire (gown, mask, gloves, hairnet) for extended periods.
Education and Experience
-
High School Diploma or GED required.
-
Associate degree, trade school, or technical training in manufacturing, electronics, or biomedical engineering preferred.
-
Minimum 6 months – 1 year of cleanroom, assembly, or production experience preferred.
-
Proficiency with Microsoft Office and basic computer data entry.
Work Environment
-
Work performed primarily in an ISO Class 8 cleanroom; adherence to strict hygiene, gowning, and cleanliness protocols required.
-
Must be able to stand for long periods and perform repetitive assembly motions.
-
May involve handling small tools, adhesives, tubing, and precision instruments.
-
Team-oriented production environment with cross-functional collaboration between quality, engineering, and supply chain.
-
Occasional overtime may be required based on production demands.
Compensation and Benefits
Based on current regional salary data for cleanroom assembly technicians in Southeast Michigan:
-
Estimated Pay Range: $18 – $26 per hour (approximately $37,000 – $54,000 annually) depending on experience, shift, and certifications.
-
Typical Benefits: medical, dental, and vision insurance; 401(k) with employer match; paid holidays and vacation; uniform/cleanroom gear provided; professional development and advancement opportunities.
Sources: Indeed – Michigan Clean Room Technician Salaries, Glassdoor – Plymouth, MI.
O*NET Code
51-2099.00 – Assemblers and Fabricators, All Other
Alternate Titles: Cleanroom Assembler, Medical Device Assembler, Manufacturing Technician
Description: Assemble or modify precision medical devices and components in a controlled environment; may perform testing and inspection to ensure products meet specifications and regulatory standards.
How to Apply
Submit your resume and any relevant certifications or references through the MTS Careers Portal under “Clean Room Assembly Technician.” Please include details of any prior cleanroom or medical device experience.
