Process Engineer I
Process Engineer I
Posted on :
23-06-2025
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1 Vacancy
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Job Description
For further inquiries regarding the following opportunity please contact our Talent Specialist:
Nagarajan at
Title: Process Engineer I
Location: Durham NC
Duration: 11 Months
Work Schedule: Standard business hours; Monday Friday; off hours depending upon project / rotation
Description:
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
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 Bachelors degree in engineering material science physics physical science or other related science degree program
0-3 years experience in engineering or manufacturing environments
Minimum Bachelors 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
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..)
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..)
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Employment Type
Full Time
Key Skills
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