Cleanroom Operator I

Indianapolis, IN

About SonaCare Medical:

SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.

Summary:

The Cleanroom Operator I is responsible for the assembly, testing, inspecting, and packaging of medical devices per work instructions 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 understand and 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 SonaCare Medical 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

Other duties as assigned

Qualifications/Specifications:

High school diploma or equivalent, required

Previous experience in the medical device industry, or other regulated industry, preferred

Good verbal and written communication skills

Ability to complete paperwork accurately in English

Ability to work safely around chemicals and equipment

Ability to stand or sit for long periods of time

Ability to do repetitive work, requiring strong dexterity and hand/eye coordination

Ability to lift up to 25 lbs

Attention to detail

 

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