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Company Contact Info
- Round Lake, IL
- Prabhu Jayapal
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Engineer III (Medical Product, Product Development, Drug Containers, DHF)
DivIHN Integration Inc • Round Lake, IL
Posted 1 month ago
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1. Medical Device Product Development; Data Analysis-Minitab, Excel (pivot tables, v-lookups, etc), Design verification, contractor integrity, product requirements DHF management, protocol writing and analysis are minimum requirements.
2. Plastic containers for intravenous injections (ISO 15747:2010)
3. DOORS (nice to have)
4. Risk Assessment Categorization Tool (RACT) is designed to allow users to determine a risk mitigation plan for studies. (nice to have)
5. Sterile Packaging maybe a better keyword than container and manufacturing experience is a plus but not a minimum requirement.
1) Act independently with minimal supervision to conduct smaller projects. Expected to make suggestion on improvements based on recent technical knowledge.
2) Writing test protocols and reports.
3) Perform basic statistical analysis and interpret functional testing results. Demonstrated experience with Minitab is preferred.
4) Contribute to the planning and execution of components of the PDLM process, which apply to product revision or enhancement or a defined piece of a larger project.
5) Ability to manage routine small projects without assistance.
6) Investigate and perform root cause investigations and provide design improvement suggestions. Recommend design improvements.
1) Knowledge of the basic principles in various engineering disciplines. (e.g. manufacturing processes, material (polymer) mechanics, DMAIC)
2) Demonstrated experience writing test protocols and reports. Strong technical writing ability.
3) Basic statistical analysis and initial training in concepts of Six Sigma quality techniques.
4) Must know how to effectively run projects and direct the activities of a technician.
5) Medical device or drug experience or highly regulated experience is preferred.
- Bachelor of Science in Engineering (ChE, ME, Polymer Eng, IE, Bio M).
- 3-5 years medical product experience focused around product development and lifecycle management
- Data Analysis
- Minitab and Excel (pivot tables, v-lookups, etc)
- Design verification, container integrity, product requirements
- Plastic containers for intravenous injections (ISO 15747:2010)
- DHF management, protocol writing and analysis are minimum requirements.
- DOORS (nice to have)
- Sterile Packaging / container and manufacturing experience is a plus, but not minimum requirement.
Local candidates only!
Interview Platform: phone followed by onsite interview
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.