Sterilization Process Engineer
DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us at to learn more and view our open positions.
Please apply or call one of us to learn more
For further inquiries regarding the following opportunity, please contact our Talent Specialist:
Hari | 224 - 507-1278
Title: Sterilization Process Engineer
Location: Durham, NC
Duration:12 Months
Hours:
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
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
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.
Employers have access to artificial intelligence language tools (AI) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Report this job
Dice Id:
10109463
Position Id:
2025-10503
DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us at to learn more and view our open positions.
Please apply or call one of us to learn more
For further inquiries regarding the following opportunity, please contact our Talent Specialist:
Hari | 224 - 507-1278
Title: Sterilization Process Engineer
Location: Durham, NC
Duration:12 Months
Hours:
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
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
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.
Employers have access to artificial intelligence language tools (AI) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Report this job
Dice Id:
10109463
Position Id:
2025-10503
Job ID: 490596293
Originally Posted on: 8/24/2025
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