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Cleanroom Operator I

Company: Sonablate Corp
Location: Indianapolis
Posted on: November 22, 2021

Job Description:

Sonablate Corp. Welcome to an established company, with a proven product, and a start-up feel. Sonablate Corp. was created following an acquisition of SonaCare Medical, LLC in 2021. 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 Corp. has two offices: one in Charlotte, NC and the other in Indianapolis, IN as well as remote employees spread out across the country. We stay focused by having monthly town hall meetings, tracking our progress toward annual goals, and passing all new projects through a rigorous vetting by our prioritization committee. We strive for transparency and clear communication throughout the company and look for candidates that want to dive in, effect change, and challenge us to become the best version of ourselves. Our employees enjoy competitive salaries, bonus plans, and an employee stock option plan. Additionally, the company pays for 90% of the employee's healthcare benefits, which are effective the first of the month following your first day on the job. We offer flexible working schedules for our hourly employees and a work-from-home policy for our salaried ones. We believe in giving our employees autonomy, mastery, and purpose and enjoy low turnover due to that philosophy. 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.--
The RoleThe 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.--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
    • 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

Keywords: Sonablate Corp, Indianapolis , Cleanroom Operator I, Other , Indianapolis, Indiana

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