SCOPE OF POSITION:

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.

DAY-TO-DAY 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)

• Provides 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

• Documents 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

• occasionally must flex working schedule as required to meet business needs

• Provide indirect leadership to assigned technical and hourly associates to achieve departmental quality, quantity, service, cost, and safety goals

Required Education/Years and Area of Experience:

• 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

Required Experience/Skills:

• Creative/innovative problem solving
• Able to collaborate across organizational boundaries and integrate solutions
• 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 Experience/Skills:

• Broad knowledge of sterilization techniques and fundamentals
• Become a subject matter expert in sterilization technology
• Experience with radiation technology, electron beam (e-beam) nuclear applications, physics, gamma irradiation or technology transferable to product sterilization via radiation technologies
• Experience within the Life Sciences or medical device industries
• Medical device quality systems and sterility assurance requirements
• 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 )