AtriCure Inc.
Published
10/12/2020
Location
Mason
Category
Job Type
Contact Name
Rita Walstrom
Street Address
7555 Innovation Way

Description

As a leading provider of innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions, electrophysiologists and cardiothoracic surgeons around the globe count on AtriCure to deliver best-in-class solutions that can treat even the most complex cases. Our Isolator® Synergy™ Ablation System is the first and only medical device approved by the FDA for the treatment of long standing persistent Afib, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, and we are expanding into pain management therapies. We invest in innovation, clinical science, and education to focus on improving lives for our patients’ worldwide.

POSITION SUMMARY:
This position is responsible for supporting the ethylene oxide (EO) product sterility assurance program by providing technical and scientific expertise to other sterilization and environmental monitoring (SEM) staff and internal AtriCure’s customers.

The incumbent functions with limited supervision, in a GMP-compliant fashion, to support new product development as well as the current portfolio of marketed products sterilized by ethylene oxide gas. The position occasionally supports the related technical disciplines of environmental monitoring and gamma radiation sterilization, and actively participates in a variety of department-specific and site-level quality systems (QS) and quality assurance (QA) activities.

The successful candidate must possess a broad array of diverse technical and scientific skills and subject matter knowledge, the ability to quickly identify and adjust to changing priorities, and the willingness and confidence to serve as the lead EO subject matter expert (SME).

ESSENTIAL FUNCTIONS OF THE POSITION:
Serve as primary reviewer of 3rd party laboratory and sterilization service provider reports for EO-sterilized products
Administer the routine EO-sterilized product bioburden analysis program
Write and/or review and disposition product bioburden data and reports
Prepare and analyze associated data trends and communicate results to management and affected disciplines (engineering, PD, Operations, etc.)
Lead cycle development, qualification, requalification activities and product-specific sterilization validations and adoptions
Provide front-end sterilization technology consultative services to product development teams; assist with scheduling, budget estimates, deliverables as needed to ensure product and project launch success and compliance with applicable regulations, industry standards, and AtriCure business objectives
Support Regulatory Affairs with the sterilization-related aspects of national and international marketing submissions
Develop and maintain the Product Sterilization Master File (PSMF) for EO-sterilized products
Perform and document periodic reviews of product-related changes and determine impact on current sterilization family groups and sterilization cycles
Perform and document periodic reviews of sterilization cycles and sterility results to confirm compliance with validated cycle parameters and load patterns
Ensure product testing services performed by 3rd party service providers comply with applicable regulations and industry best practices
Ensure the most current versions of relevant 3rd party specifications, procedures, and methods are incorporated into the PSMF and maintained in current state
Train 3rd parties as needed to perform and document product aseptic deconstruction
Deliver periodic inter- and intra-department technical training to AtriCure colleagues
Lead investigations associated with product-specific outlier data, bioburden failures, and other unexpected results
Participate as needed in AtriCure’s Change Control, CAPA, NCR, Deviation, HHE and Risk Management programs and complete actions and deliverables as assigned
Support the Gamma Radiation Product Sterilization Associate, EM QC Specialist and SEM Technician as needed, for example, during periodic time off (PTO) and high-volume work periods, by assisting with standard and nonstandard job duties; and maintaining awareness of these responsibilities by completing periodic cross-training exercises
Support department colleagues and manager and share in department administrative tasks such as:

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
Experience planning, scheduling, executing, and completing project tasks to meet deadlines
Ability to work under fast-paced conditions, prioritize duties and multitask as needed
Ability to make decisions and use good situational judgment skills
Ability to communicate with colleagues across all levels of the organization and work in cross-functional teams
Detail-oriented, with strong commitment to accuracy and completeness of work
Willing and available to work non-standard hours on occasion to support organizational and department objectives and commitments
Firm knowledge of sterility assurance and sterilization processes relevant to single-use sterile medical device manufacturing operations
Participate in cross-training activities with other department personnel and master the job skills required for serving as a backup resource for other department roles during PTO and high-work-volume periods
Experienced and comfortable working in a cGMP-regulated business; committed to compliance with all Good Manufacturing Practices and SOPs defined by AtriCure policies, practices and procedures

BASIC QUALIFICATIONS:
Bachelor's Degree in Sterilization Technology, Life Sciences, Microbiology, or related field; and 2 years of product-sterilization work experience in a medical device, pharmaceutical or laboratory environment, or a college degree plus at least 3 years of relevant, combined research, internship, and professional experience in a GXP-regulated medical device, pharmaceutical or environmental laboratory environment
Excellent writing and verbal skills
Intermediate Microsoft Office skills (Excel, Word, PowerPoint)
Data analysis and charting skills
Familiarity with 21CFR820, ISO 13485, AAMI TIR28, ISO 11135-X series of standards and related national and international medical device industry standards and regulations
Auditing experience; auditor certification would be a plus
Experience with regulatory authority inspections and certified body audits

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

TRAVEL REQUIREMENTS: Traveling away from the office to fulfill the responsibilities of this position is occasionally necessary. Travel assignments are expected to be less than <2% of annual FTE labor.

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