Operator, Clean Room Sonablate Corp. Indianapolis, IN Job Details Full-time From $18 an hour 8 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Laboratory experience Cleanroom protocols Medical device manufacturing facility experience Full Job Description The Cleanroom Operator, is responsible for assembly, testing, inspecting, and packaging of medical devices using a variety of assembly equipment, fixtures, and test equipment. The Cleanroom Operator I, will work primarily in an ISO Class 8 Cleanroom and be expected to follow requirements to maintain cleanliness levels.

Duties and Responsibilities:

Follow detailed assembly instructions, processes, and procedures to correctly assemble medical devices Comply with policies, procedures, and regulatory requirements of the Sonablate Quality System Perform manual assembly and visual inspection of medical products Complete line clearance, DHR records, training records, and other documentation as required Complete routine tasks with minimal supervision Maintain a clean and organized work area to facilitate manufacturing functions Work in a cleanroom environment which may include cleaning and monitoring activities The Company Welcome to an established company, with a proven product, and a start-up feel. We have designed, developed, manufactured, sold, and serviced the Sonablate HIFU ablation device for over two decades, receiving 510K de novo clearance with the FDA in 2015. The Sonablate device is cleared in more than 50 countries, including a CE Marking in the European Union and approval from the National Medical Products Administration in China. Sonablate provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws.

Job Type:

Full-time Pay:

From $18.00 per hour

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Experience:

Clean Room:

Medical Device:

3 years (Required)

Medical Device Assemblers:

1 year (Required) Shift availability: Day Shift (Required)

Work Location:

In person