Product Sterilization Scientist

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 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. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

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:

• Working with colleagues from multiple departments and 3rd party providers to plan and execute projects and ensure accurate and timely project completion

• Maintaining the department's hard-file and electronic system for retention of technical and business records

• Using the MasterControl electronic document management system (EDMS) to write, review, edit, and route technical and administrative SOPs, forms, and work instructions

• Training 3rd party providers as needed to comply with AtriCure policy for access to controlled environments and utility systems

• Obtaining quotes and POs for relevant goods and services, and tracking/reporting expenditures against approved POs

• Maintaining the Department e-mailbox and electronic records directory; maintaining connectivity/access rights to various 3rd party customer portals and staying abreast of incoming/outgoing communications

• Supporting on-site audits of 3rd party laboratory and sterilization service providers by participating in audit execution, identification and communication of findings, audit report development, and tracking the resolution and suitability of identified corrective actions under the direction of the lead auditor

• Conducting postal audits of 3rd party laboratories and sterilization service providers by maintaining the audit schedules, tracking resolution of findings from previous audits, generating requests for information, creating and delivering questionnaires, reviewing responses, identifying findings, writing reports

• Assisting Supplier Quality department with development and issuance of SCARs for 3rd party laboratory and sterilization service providers; assisting with determination of appropriate corrective actions, and tracking/reporting progress through resolution and closure

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 needed

• Ability to occasionally bend and push/pull as needed

• 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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AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits. AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

Other details

• Job Family Sterilization & Environmental Controls

• Job Function Quality

• Pay Type Salary

• Employment Indicator Non Manager

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