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We foster an inclusive culture and are looking for diverse, talented people to join Alcon and we are looking for an Associate Director, Reprocessing Engineering to join our team in Lake Forest, CA.
Responsibilities:
As corporate SME interprets regulatory standards or guidance relating to reprocessing and translates into local and corporate procedures.
Establishes global implementation strategy and timelines for new or updated standards.
Provides detailed analysis of standards and impact on existing technical files. Partners with sustaining engineers to properly maintain reusable product technical files.
Proactively monitors literature, standards, industry guidance, trends, and customer reprocessing expectations globally.
Rapidly assimilates new technology and requirements, evaluates long term organizational needs in reprocessing.
Monitors and represents Alcon globally on select reprocessing standards committees.
Collaborates with Marketing, CASs, and HFE's to optimize reprocessing for customers and create global competitive advantage.
Guides NPI teams globally in developing suitable reprocessing methods, instructions, and requirements.
Guides engineers during product lifecycle activities relating to reprocessing requirements.
Provides guidance to reprocessing label development or updates to meet evolving regulatory and customer requirements.
Provide SME input during regulatory or corporate audits, and regulatory submissions.
Collaborates with RA/QA and Med Info Teams to develop materials to address customer inquiries.
Provides SME input for inquiries from customers, regulators, or Alcon staff relating to execution, content, and alternatives to reprocessing instructions.
Major Accountabilities
Performs corporate level assessments of emerging, newly published, or recently altered standards impacting the reprocessing field.
Leads critique/evaluation of product design and directions for use with respect to reprocessing objectives.
Provides expert technical guidance, maintains local and corporate reprocessing procedures, directs/conducts reprocessing verifications.
Works with teams to address reprocessing challenges, design reprocessing methods, and validate methods to support project objectives.
Develops superior cleaning, disinfection, drying, and sterilization test methods as needed to advance state of the art practices and customer needs.
Provides QA/RA with summaries or guidance in regulatory submissions, audits, or preparing IFUs.
Develops in-depth understanding of configuration, application, and engineering of reusable devices, establishes product families and adoption practices.
Leads efforts to select/approve external labs as strategic partners in developing better reprocessing regimens; develops in house test methods as feasible.
Collaborates with PSE to ensure technical files are updated as needed to stay compliant to current standards.
Lead efforts to address customer inquiries, develop FAQ resources with RA/QA or Global Med Info groups.
Create (or oversee) protocols, coordinate testing, verification reports, needed to support reprocessing instructions. Identify when reverification is required.
Experience:
10+ years of experience in QSR/EU MDR compliant medical device development including ability to:
Provide global technical leadership. Influences effectively in a cross-functional environment (e.g. multi-site, NPI, customer inquiry support)
Provide SME interpretation of: ISO 11135, ISO 11138-X, ISO 10993-X, ISO 17664-1/-2, ISO 17665-X, ISO 11607-X, ISO 15883-X, EN 13060, EN 285, AAMI ST 79, AAMI TIR 12/30, AAMI ST8, AAMI ST98, ISO 14161, EN 14885, EN ISO 11737-X, FDA Endotoxin and Reprocessing guidelines, RKI Guidance, MHP Central Sterilization supplements.
Effectively communicate complex concepts in presentations, regulatory submissions, and in technical reports to global audiences.
Develop reprocessing methods, lead IFU validations, resolve cleaning and sterilization concerns during development.
Apply detailed knowledge of common microbiological and biochemical laboratory methods (sterility & disinfection testing, protein/TOC/endotoxin assays, etc.)
Key Requirements/Minimum Qualifications:
Bachelor’s Degree or Equivalent years of directly related experience (or high school+15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
The ability to fluently read, write, understand, and communicate in English.
7 Years of Relevant Experience
Work hours: M-F, standard
Travel Requirements: 10%
Relocation assistance: yes
Sponsorship available: yes
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Pay Range
$132,560.00 - $198,840.00
Pay Frequency
Annual
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
