Sr. Sterilization Engineer
The Sr. Engineer, Sterilization provides subject matter expertise to project teams to drive all sterilization-related activities as it relates to research and development of health care products. The successful candidate will have a background in microbiological principles as it relates to sterility assurance and practical experience utilizing multiple sterilization technologies: ethylene oxide, radiation (gamma and electron), and moist heat.
Leads the identification and selection of appropriate sterilization technology and management of sterilization validation efforts for products to assure the sterilization process is robust and compliant with regulations, standards and company policies and procedures.
location: Scottsdale, Arizona
job type: Permanent
salary: $105,000 - 110,000 per year
work hours: 9 to 5
- Serve as subject matter expert for the development, validation and maintenance of sterilization processes.
- Drive the identification and implementation of innovative solutions to project challenges.
- Develop test methods, procedures and validation protocols to achieve project goals and objectives.
- Partner with team members, customers, and suppliers as required to achieve project objectives.
- Serve as senior sterilization resource to project teams.
- Mentor junior personnel in sterilization concepts.
- Communicate activities and project timelines management
- Perform other duties as assigned based on business needs.
- Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
- Exhibit regular, reliable, punctual and predictable attendance.
- Demonstrate ability to multi-task and prioritize work activities.
- Author and/or approve protocols, reports, and risk assessments for new products, and product and process design changes.
- Ensure compliance with the appropriate industry and government regulations.
- Support operations by authoring or approving procedures and providing training and guidance to production and quality assurance personnel.
- Lead initiatives on behalf of the Global Sterilization Council
- Assess sterilization trends and alternative technologies through literature, networking, and intellectual property.
- Serve a company representative to sterilization industry standards organizations.
- Support regulatory and customer audits (sterilization-related).
- Bachelor's degree in in physical sciences, such as Microbiology, Biomedical Engineering or related engineering discipline
- 5-7 years of experience in health care product development and validation of sterilization processes.
- Practical knowledge of sterilization principles and prior education or experience with health care product design and/or manufacturing processes, microbiological test methods, validation
- Must have effective problem-solving abilities and strong interpersonal and communication skills (both written and oral)
- Must be dependable, detail oriented, and able to multi-task
- A sense of urgency/initiative
skills: Microbiology, Biomedical Engineering
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.