009V6001 Project Engineer/Risk Management (Pharma/Med Device)
Indianapolis, IN
Full Time
Mid Level
009V6001 Project Engineer/Risk Management (Pharma/Med Device)
Please contact Amanda Mazza, [email protected]
***FTE ONLY***
SUMMARY
We are seeking a Risk Management Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.
You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.
KEY RESPONSIBILITIES
LOCATION
Indianapolis, IN
EMPLOYMENT
Full-time employment only
Please contact Amanda Mazza, [email protected]
***FTE ONLY***
SUMMARY
We are seeking a Risk Management Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.
You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.
KEY RESPONSIBILITIES
- Support the development and deployment of risk management deliverables in alignment with ISO 14971
- Serve as subject matter expert for the Turbo AC Software System
- Facilitate and author the migration activities of FMEAs from an existing Software System into Turbo AC
- Conduct working sessions to guide teams on how to use the Turbo AC Software System
- Document bugs and tangible upgrade features to share with the Turbo AC Development team
- Creating and Running test scripts to support Turbo AC upgrade Validation
- Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design
- Create/update standard operating procedures
QUALIFICATIONS
- Bachelor’s degree in engineering, biomedical, systems, or related field
- 3-5 years of experience in medical device development or risk management
- Knowledge of ISO 14971
- Experience creating and reviewing FMEAs and other risk tools
- Strong organizational and communication skills, especially in cross-functional settings
- Proficiency with Microsoft Office tools such as Excel, PowerPoint
- Experience with risk management tools like TurboAC or QMSpace
- Familiarity with the design control processes under FDA and EU MDR frameworks
- Experience with Change Control Trackwise or Veeva OneQMS
LOCATION
Indianapolis, IN
EMPLOYMENT
Full-time employment only
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