AtriCure Job - 30635157 | CareerArc
  Search for More Jobs
Get alerts for jobs like this Get jobs like this tweeted to you
Company: AtriCure
Location: Cincinnati, OH
Career Level: Entry Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Position/Title:

Product Sterility & EM Support Technician

Department:

Sterilization and Environmental Monitoring

Reports To:

Manager, Sterilization and Environmental Monitoring

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator ® Synergy™ Ablation System is the first and only medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

POSITION SUMMARY:

This position has the responsibility to support the Mason OH manufacturing facility's environmental monitoring program, the daily operations of the environmental quality control laboratory, and the product sterility assurance program for gamma-sterilized and EO-sterilized products. The position is responsible, under general supervision, for collection of samples, coordination of sample analyses, assisting with data compilation and reporting, and providing general technical and administrative support to department personnel and the department's internal and external customers.

ESSENTIAL FUNCTIONS OF THE POSITION:

  • Collect environmental samples from water, compressed air, room air and surfaces, according to SOPs using proper aseptic technique
  • Document and report sample collection activities and analytical results
  • Prepare EM and product sample submission/chain of custody forms for samples to be analyzed by 3rd party laboratories
  • Prepare environmental and product samples for shipment
  • Assist with preparation of EM and product bioburden and endotoxin trend charts
  • Perform and document routine QC instrument and equipment periodic control checks
  • Maintain inventory of laboratory and product sampling/testing supplies, reagents, and materials
  • Interface with 3rd party goods and services suppliers to obtain purchase quotes and to request/receive reports
  • Assist with preparation and distribution of product quarterly dose audit, validation, and adoption reports
  • Assist with tracking and reporting department expenditures against approved purchase orders
  • Maintain department's electronic and hard-copy document and record repository
  • Maintain department's communication mailbox
  • Participate in SOP and work instruction development or revision initiatives
  • Participate in other product sterility assurance and environmental program studies and duties under general supervision, as required
  • Follow all Good Manufacturing Practices and SOPs as defined by AtriCure policies, practices and procedures to ensure that FDA regulations and ISO standards are met.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

  • Regular and predictable worksite attendance
  • Ability to work under fast-paced conditions
  • Availability and willingness to work non-standard hours on occasion to support project-specific and department-level tasks
  • Ability to make decisions and use good judgment
  • Ability to prioritize various duties and multitask as required
  • Ability to successfully work with others

BASIC QUALIFICATIONS:

  • High school diploma or equivalent required with 1 year of direct relevant experience, supplemented by 2 years of workforce experience OR Associate degree or higher in life science
  • Computer/data entry skills
  • Basic spreadsheet-based data entry skills
  • Basic report writing skills
  • Good interpersonal verbal and written communication skills
  • Familiarity with functions and features of Microsoft (MS) Office suite products (Excel, Word, PowerPoint) and recent “hands-on” MS Office experience

PREFERRED QUALIFICATIONS:

  • Associates Degree

OTHER REQUIREMENTS:

  • Ability to regularly walk, sit, or stand as required
  • Ability to occasionally bend and push/pull
  • Ability to periodically lift up to 25 pounds, occasionally lift up to 50 pounds
  • Ability to pass pre-employment drug screen and background check


 Apply on company website