| Brief job description | You will use systems engineering knowledge & processes to identify and control risks on assigned products.
Your contributions will ensure our products continue to deliver maximum benefit to our customers and patients that rely on them.
The successful candidate will possess strong technical capabilities think at multiple levels (stakeholders system design detail) enjoy cross -functional teamwork and demonstrate a passion for their work and the impact it has on saving and sustaining the lives of patients.
The resource shall act as subject matter expert to assist functional owners of elements of the risk management file with planning and execution. Demonstrated ability to communicate with a wide set of stakeholders (Quality MA PM RA Marketing etc.). Demonstrated understanding of the end-to-end process of identifying stakeholder needs translation to Design Inputs and tracing these to the Design Outputs. Demonstrated understanding of operational workflows functional & physical architectures & their use for analyzing hazardous situations. Demonstrated understanding of Systems Engineering driven process for achieving ISO 14971 compliance. All work shall be performed in accordance with Baxter policies and procedures for design control and risk management. |
| Top 2-5 must have skills/experience | 1) Systems Engineering training and/or education
2) Design experience (e.g. EE SW ME System)
3) Experience in highly regulated industries (Medical Aerospace Nuclear etc.)
4) Demonstrated understanding of operational workflows functional & physical architectures & their use for analyzing hazardous situations.
5) Excellent communicator |
| Division and product lines the contractor will work on/with | FLC division
Connected Monitoring
Intelligent Diagnostic
Cardiac
Vision
Respiratory |
| Key deliverables and project milestones expected during the assignment | Risk Management Plan & Report
Creation & Usage of User Workflows Context Diagram(s) Functional Flow Block Diagram(s)
Functional Hazard Analysis (includes Software Hazard Analysis)
Identification of critical functions & components
Risk Assessment Summary (linked to lower level Risk assessments)
Periodic & Event Based Risk Review
Risk Impact Assessment |
| Preferred tools technologies and systems the contractor should be familiar with | Polarion
Word/Excel/Visio |
| Team structure and key stakeholders theyll interface with | They will be assigned as the systems engineer performing analysis for patient safety risk impact.
There will typically be the following roles:
PM - schedule/budget/task tracking/etc.
PDO - Systems Engineer leading the design updates.
PRMO - Product Risk Management Owner - leading & performing the risk analysis for the project.
MA - Medical Affairs - responsible for assessing potential harm severities |
| Work environment | Virtual |
| Remote/onsite expectations | Remote |
Brief job description You will use systems engineering knowledge & processes to identify and control risks on assigned products. Your contributions will ensure our products continue to deliver maximum benefit to our customers and patients that rely on them. The successful candidate will posse...
| Brief job description | You will use systems engineering knowledge & processes to identify and control risks on assigned products.
Your contributions will ensure our products continue to deliver maximum benefit to our customers and patients that rely on them.
The successful candidate will possess strong technical capabilities think at multiple levels (stakeholders system design detail) enjoy cross -functional teamwork and demonstrate a passion for their work and the impact it has on saving and sustaining the lives of patients.
The resource shall act as subject matter expert to assist functional owners of elements of the risk management file with planning and execution. Demonstrated ability to communicate with a wide set of stakeholders (Quality MA PM RA Marketing etc.). Demonstrated understanding of the end-to-end process of identifying stakeholder needs translation to Design Inputs and tracing these to the Design Outputs. Demonstrated understanding of operational workflows functional & physical architectures & their use for analyzing hazardous situations. Demonstrated understanding of Systems Engineering driven process for achieving ISO 14971 compliance. All work shall be performed in accordance with Baxter policies and procedures for design control and risk management. |
| Top 2-5 must have skills/experience | 1) Systems Engineering training and/or education
2) Design experience (e.g. EE SW ME System)
3) Experience in highly regulated industries (Medical Aerospace Nuclear etc.)
4) Demonstrated understanding of operational workflows functional & physical architectures & their use for analyzing hazardous situations.
5) Excellent communicator |
| Division and product lines the contractor will work on/with | FLC division
Connected Monitoring
Intelligent Diagnostic
Cardiac
Vision
Respiratory |
| Key deliverables and project milestones expected during the assignment | Risk Management Plan & Report
Creation & Usage of User Workflows Context Diagram(s) Functional Flow Block Diagram(s)
Functional Hazard Analysis (includes Software Hazard Analysis)
Identification of critical functions & components
Risk Assessment Summary (linked to lower level Risk assessments)
Periodic & Event Based Risk Review
Risk Impact Assessment |
| Preferred tools technologies and systems the contractor should be familiar with | Polarion
Word/Excel/Visio |
| Team structure and key stakeholders theyll interface with | They will be assigned as the systems engineer performing analysis for patient safety risk impact.
There will typically be the following roles:
PM - schedule/budget/task tracking/etc.
PDO - Systems Engineer leading the design updates.
PRMO - Product Risk Management Owner - leading & performing the risk analysis for the project.
MA - Medical Affairs - responsible for assessing potential harm severities |
| Work environment | Virtual |
| Remote/onsite expectations | Remote |
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Job Location:
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
