Process Engineer

•    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

•    Must respond to off-hours calls (rotating coverage schedule) to resolve process upsets or systems downtime events; 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

 
TRAVEL REQUIREMENTS:
•    None 

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..)