Senior 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 AtriCure Sterilization Programs, specifically in gamma radiation and/or ethylene oxide modalities, by providing technical and scientific expertise to the Quality Operations staff and internal AtriCure customers. The Senior Sterilization Scientist works within the prescribed GMP/ISO Standards and ensures compliance to applicable domestic and international regulations. The Senior Sterilization Scientist is tasked with leading or supporting projects such as sterilization cycle/process development, management of sterilization cycle validations, product sterilization adoptions, change control assessments, improving sterilization and product microbiology programs and ensuring on-going sterilization effectiveness. This position will be responsible for sterility assurance for routine processing and managing product bioburden and endotoxin programs.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Apply knowledge of sterilization process and the associated microbiological concepts and practices for terminally sterilized single-use devices, as required to comply with relevant ISO standards, industry guidelines, and national / international regulations.
• Act as a sterilization and microbiology subject matter expert (SME), by supporting new product development, changes to existing commercial products, and associated domestic and international regulatory filings.
• Guide product development teams with scheduling, budget estimates, deliverables, as needed to ensure project and product launch success, and compliance with applicable regulations, industry standards, and AtriCure business objectives.
• Provide technical solutions to product development and engineering teams using various fields of science and sterilization theory and practice.
• Lead cycle development, validation, requalification activities, as well as product-specific sterilization qualifications and adoptions.
• Manage, perform and document periodic product reviews and annual cycle reviews to determine impact on current sterilization family groups and sterilization cycle effectiveness. Recommend actions to be taken, as needed, to maintain program effectiveness.
• Analyze/review chemical, biological, or microbiological results for raw materials, in-process materials, validation samples and product release test samples (includes, bioburden, organism, EO/ECH residual levels, BI testing, etc.).
• Perform product release activities, as required.
• Guide teams through effective sterilization impact assessments within change control activities. Mentor team for approach to assessment and deliverables to meet effective, and consistent practice aligning with internal programs and external requirements.
• Accountable for maintenance, and improvement of sterilization, bioburden and endotoxin programs.
• Develop protocols and reports to document project, product, and process outputs.
• Support strategy, development and integration of new sterilization modalities into current programs and processes.
• Collaborate in the development and integration of upstream processes used to control biocontamination such as, product/component cleaning processes, facility cleaning and disinfection, and environmental controls.
• Lead internal and 3^rd party investigations (i.e. dose audit failure, endotoxin product failures) in response to failures or negative trending within the program requirements.
• Support 3^rd party quality system audits for relevant suppliers (ie, sterilization vendors, test laboratories).
• Deliver periodic internal technical training to AtriCure colleagues.
• Participate as needed in AtriCure CAPA, NCR, Deviation, HHE and Risk Management programs and complete actions and deliverables as assigned.
• Support department in administrative tasks such as, but not limited to;

• • Liaison between AtriCure and 3^rd party vendors for project scope, quotes, invoices, and training as needed to comply with AtriCure policies and procedures.
  • Tracking/reporting expenditures against approved Purchase Orders.
  • Maintain department electronic file system for retention of technical and business records, such as cycle specification, test specifications, and dose maps.
  • Use electronic document management system(s) to write, review, edit and route technical and administrative documentation.
  • Coordinate product and sample shipping to 3^rd party vendors.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to remain calm and respective and maintain productivity in fast paced situations
• Ability to make decisions and use good judgement
• Ability to prioritize various duties and multitask as required
• Ability to communicate effectively across all levels of the organization and work in cross functional teams
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor’s degree in microbiology, life sciences or related field; and minimum of 5 years of sterilization work experience in a GXP regulated environment, such as medical device and/or pharmaceutical, OR an advanced college degree plus at least 3 years of relevant experience.
• Demonstrates technical expertise, through applied experience in at least one sterilization modality, i.e. Ethylene Oxide Sterilization or in Radiation Technologies (e.g., Gamma, X-Ray, E-beam).
• Knowledge of applicable external standards; ISO 13485, ISO 11135, ISO 11137, ISO 11737, AAMI TIR28 or TIR35, and related national and international medical device industry standards and regulations.
• Excellent writing and communication skills.
• Intermediate Microsoft Office Skills (Excel, Word, PowerPoint).
• Strong analytical and mathematical skills.
• Detail-oriented, with strong commitment to accuracy and completeness of work.
• Ability to work non-standard hours on occasion to support organizational and department objectives and commitments (e.g., audits, dunnage builds, project deadlines, etc.).
• Ability to travel up to 15%. Travel to supplier and service provider sites, other AtriCure offices or industry-specific meetings or conferences.

PREFERRED QUALIFICATIONS:

• A current ASQ certification as a Quality Engineer, Quality Auditor, or Biomedical Auditor, or an equivalent certification from a comparable professional organization.
• A current certified sterilization specialist (CSS) designation by AAMI or similar professional organization, in at least one sterilization modality.
• Participatory experience with FDA inspections or ISO audits.
• Experience with regulatory requirements and submission processes for FDA, MDD/MDR, CMDR, and JPAL

OTHER REQUIREMENTS:

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

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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).