Location: San Jose, CA
Auris is a technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, Auris is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures.
As the Reprocessing Manager, this individual will provide technical and managerial leadership in developing instrument reprocessing lines and equipment maintenance. This manager will lead and oversee sterilization operation, reprocessing development, process validation and design transfer activities. The responsibility covers both production and new product development. The role has budgetary and staffing responsibility for the department.
Core Job Responsibilities:
• Provide technical leadership to establish and optimize end to end reprocessing lines for instrument cleaning and sterilization.
• Provide DFM (Design for Manufacturing) assessment in cleanability to the product development core team.
• Lead and execute cleaning validation to support regulatory submission.
• Oversee process improvements for the reprocessing operation including process verification, MFG documentation updates and process validation.
• Manage commercial reprocessing operation. Receive, decontaminate, inspect/test and sterilize surgical instrument and equipment.
• Manage sterilization and packaging operation for production and also support new product development.
• Establish and report department metrics related to production including yields, scrap rates and cycle times.
• Hire, train, develop, and review process/manufacturing engineers and manufacturing personnel
• A minimum of a BS degree is required with a focus in Chemical, Mechanical, Biomedical Engineering or equivalent.
• A minimum of 8 years experience in reprocessing, sterilization or related supply chain environment OR MS degree with 5+ year experience is required.
• Minimum 3 years in people or project management is preferred.
• Experience in creating PFMEA, leading process validation (IQ/OQ/PQ) planning/execution is preferred.
• Experience with manufacturing process/equipment design and development is required.
• Experience with sterility assurance is preferred.
• Understanding of engineered materials and fabrication methods is preferred.
• Experience with reprocessing of reusable medical devices, especially those with long lumens, is preferred.
• Ability to manage multiple priorities in fast-paced environment.
• Excellent people and project management skill.
• Excellent knowledge of 21 CFR part 820 and ISO 13485 is preferred.
• Knowledge or experience with surgical instrument cleaning technology and Enzymatic cleaner and surfactant chemistry is preferred.
• This position is located in San Jose, CA, and may require up to 10% of travel both internationally and domestically.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.
Position Type and Expected Hours of Work
This is a full-time position. Days and hours of work are flexible Monday through Friday, generally 8:30 a.m. to 5:30 p.m. Occasional evening and weekend work may be required as job duties demand.
United States-California-Redwood City-
North America-United States-California-San Jose
Auris Health, Inc. (6267)