Job Description
Job Description
In this role, you will be responsible for supporting sterilization technology and terminal sterilization processes across the division. We look for you to support of development, engineering, and manufacturing projects. You will need to collaborate with cross-functional teams including but not limited to Operations, Quality, Engineering, and Division Engineering. Primary responsibility will be support of internal sterilization equipment, process, and technology as well as interface with outside vendors.
Responsibilities:
- Actively collaborate with other site engineers, operations personnel, and suppliers to maintain and improve operations
- Work with operations to gather support needed, information, and provide updates on process status
- Quickly respond to production and process upsets, troubleshoot production issues, diagnose problems, and implement corrective action (machine fix, process change, etc.) to reestablish operations
- Work with operations to further develop SPC/SQC for process discipline and control (PD/PC)
- Provide technical leadership in assigned processes and escalate issues appropriately
- Act to continuously improve and expand the core process capabilities
- Use of engineering first principles like MEE to drive mechanistic understanding and root cause identifications
- Responsible for providing technical expertise and strategic direction for sterilization
- Supporting and executing activities related to development, validation, routine sterilization and requalification activities
- Lead and work collaboratively across project teams as assigned, which may include commercial product support, continuous improvement activities, innovation projects, or other activities related to sterilization
- Reviewing and analyzing process data for trends and improvement areas
- Monitor internal asset performance with focus to 98% uptime
- Document changes via the change control process
- Train maintenance and operations personnel on processes and machinery to transfer operations knowledge and ensure operational efficiency and product quality
Required Qualifications:
- Minimum Bachelor’s degree in engineering, material science, physics, physical science or other related science degree program
- 0-3 years experience in engineering or manufacturing environments
- Strong experimental practices and engineering problem solving; can understand fundamentals and recognize deviations and implement routine solutions
- Proficient in the use of software programs such as MS Word, Excel, PowerPoint
Desired Qualifications:
- Broad knowledge of sterilization techniques and fundamentals
- Experience within the Life Sciences or medical device industries
- Knowledge of medical device quality systems and sterility assurance requirements
- Experience with radiation technology, electron beam (e-beam) nuclear applications, physics, gamma irradiation or technology transferable to product sterilization via radiation technologies
- DMAIC and/or lean manufacturing principles
- Equipment and product design and validation experience
- Familiarity with radiation, heat, filtration, and chemical sterilization methods and associated international standards (ISO 11135, ISO 14937, ISO 11137, ISO 13408)
- Working knowledge of microbiological testing, biocompatibility and associated international standards (ISO 11737, ISO 11138, ISO 14161, ISO 10993) required to support sterilization process validation
- Experience working with data analysis software (JMP, Minitab, etc..)
Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.
Browse our website below for additional information on our company.
The Fountain Group
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”
Company Description
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.\r\n\r\nBrowse our website below for additional information on our company.\r\n\r\nThe Fountain Group\r\n\r\n“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”