In this role as a Senior R&D Sterilization Engineer, you will use sound and proven engineering principles, best practices and concepts to assist in designing and developing robust sterilization cycle and process for new medical device products and it packaging to ensure product & package integrity is maintained throughout shipping and distribution environment. You will be generating experiments for robust sterilization process (high throughput), testing, analyzing, and selecting materials for packaging based on durability and cost effectiveness. Working as a member of a R&D Mechanical Packaging team, you will collaborate and communicate with other engineers, management, and operators.
· Lead/support in design development of Medical device and Packaging system for terminally Ethylene oxide sterilization process.
· Plans and performs Design of Experiments (DOE) to characterize and determine optimal ETO sterilization processing parameters.
· Provide technical assistance and drive early development of scaling up ETO sterilization processes from single unit to multiple pallet level load.
· Ability to resolve complex process/product development and manufacturing issues independently and/or take lead of working cross functional teams.
· Provide technical guidance for appropriate material selection which are compatible with ETO sterilization.
· Familiarize with Ethylene Oxide sterilization cycle phases (pre-conditioning, conditioning, exposure and degas) and other sterilization methods.
· Confers with vendors, management, engineering, and other staff to determine product specifications and capabilities
· Demonstrate hands-on technical understanding and provide guidance and training to junior engineers and technicians on test methods and data analysis techniques
· Implement changes to commercial packaging systems as necessary to support corporate objectives. This typically includes identifying requirements, gaining multi-department buy-in, communicating with vendors, creating and updating documentation, and processing through document control system.
· Develop and maintain technical project timelines and provide updates and feedback to project and R&D Packaging leadership.
· Provide technical oversight and coordinate R&D builds within a pilot production facility for multiple projects and project teams.
· Exercise judgment within defined procedures and policies to determine appropriate action.
· This position assumes and performs other duties as assigned.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
• Proven track record to run self-directed projects, maintain timelines, and execute in a fast-paced environment
• Proven track record to design Medical device and/or Packaging System for terminally ETO/Gamma & Radiation sterilized product.
• Knowledge of high reliability, high volume manufacturing processes and designs
• Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things
• Previous direct involvement in regulated medical device industry process development
• Proficiency in the use of SolidWorks or equivalent CAD software
• Strong proficiency with data analysis methods and JMP or equivalent statistical software
• Demonstrated competency in experimental design, execution, and interpretation of data
• Detail oriented with strong time management skills
• Excellent communication (written and verbal) and personal interaction skills
• Working knowledge of 21 CFR 820, ISO 13485, ISO 10993, ISO 11135, ISO 11137, ISO 14644
• Familiar with various standards for terminally sterilized packaging system for sterile and non-sterile per ISO 11607-1/2, ASTM & EN standards
• B.S. in Packaging Engineering or Mechanical Engineering or equivalent with 5+ years related experience or M.S. in Packaging Engineering or Mechanical Engineering or equivalent with 3+ year related experience in an FDA regulated environment preferably in Medical Device/Pharma.
• Knowledge of Design for Six Sigma and/or Lean Six Sigma will be a plus.
• B.S. or M.S. in Mechanical Engineering or Biomedical Engineering or Packaging Engineering or equivalent
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