AtriCure, Inc. · 7 hours ago
Senior Product Sterilization Scientist
Mason, OH
Full-time
Onsite
Senior Level
5+ years expAtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. The Senior Product Sterilization Scientist will support AtriCure Sterilization Programs by providing technical expertise and ensuring compliance with regulations, while leading sterilization cycle development and validation projects.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
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 3rd party investigations (i.e. dose audit failure, endotoxin product failures) in response to failures or negative trending within the program requirements
Support 3rd 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 3rd 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 3rd party vendors
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
Qualification
Required
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
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
Preferred
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
Benefits
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
Full access to our on-site fitness center and cafeteria
Company
AtriCure, Inc.
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide.
1001-5000 employees
H1B Sponsorship
AtriCure, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (7)
2022 (10)
2021 (5)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$201MKey Investors
U.S. Venture Partners
2020-05-12Post Ipo Equity· $175M
2005-08-05IPO
2002-06-10Series Unknown· $21M
Leadership Team
Michael H. Carrel
President and Chief Executive Officer
Tamer Ibrahim
Vice President, Research & Technology
Company data provided by crunchbase