What are the responsibilities and job description for the Senior Product Sterilization Scientist position at AtriCure, Inc.?
p Osition Summary
This position is responsible for supporting the AtriCure Sterilization Programs, specifically in gamma radiation and ethylene oxide modalities, by providing technical and scientific expertise to the Sterilization and Environmental Monitoring (SEM) 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 cycle/process development, management of existing 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
This position is responsible for supporting the AtriCure Sterilization Programs, specifically in gamma radiation and ethylene oxide modalities, by providing technical and scientific expertise to the Sterilization and Environmental Monitoring (SEM) 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 cycle/process development, management of existing 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.
- Regular and predictable work performance
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgement
- Ability to prioritize various duties and multitask as required
- Ability to successfully work with others
- Additional duties as assigned
- 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.
- Ability to remain calm and respective and maintain productivity in fast paced situations.
- Ability to make decisions and use good judgement.
- Ability to communicate effectively across all levels of the organization and work in cross-functional teams.
- 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.
- 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
- 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