Risk Management Specialist

Troy, MIfull timeOn Site

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senior

H1B: no

Alten Technology Risk Management Specialist at Alten Technology supports medical device risk management with expertise in Systems Engineering. Develops, reviews, and assesses key risk management deliverables ensuring alignment with standards and integration with platform risk libraries.

Responsibilities

Development and Review of Key Risk Management Deliverables
Conduct the technical review of the PHA.
Support the development and technical review of the BE CT CHA and platform CHA, including associated platform risk libraries:
Ensure alignment with Systems Engineering deliverables (e.g., consistency between RCMs and design inputs).
Verify alignment of risks and RCMs with applicable standards (e.g., ISO 11608, IEC 60601‐1, etc.).
Support integration activities related to platform risk libraries.
Support for Additional Risk Management Deliverables
Contribute to the development and review of the Platform Risk Management Plan (RMP).
Participate in Functional Failure Analysis, including:
Identification of system-level effects.
Assignment of appropriate defect classifications.
Support additional Risk Management deliverables as required throughout the project lifecycle.

Qualification

Expertise with key standardsIEC 60601‐1 and related standardsProfessional SkillsAssignment Conditions

Required

8+ years of experience in Risk Management for medical devices.
Strong background in Systems Engineering methodologies.
Expertise with key standards, including:
IEC 60601‐1 and related standards
Experience with TurboAC or risk management platforms is a strong plus.
Professional Skills
Ability to conduct detailed and complex technical analyses.
Excellent technical documentation and writing capabilities.
High attention to detail and strong analytical mindset.
Ability to collaborate effectively with cross-functional teams, including Systems Engineering, Quality, Design, and Platform Engineering.
Assignment Conditions
On-site presence required in Indianapolis.

Preferred

Experience with TurboAC or risk management platforms

Company

Alten Technology

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Source: greenhouse

Active within the past hour

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Must-Have Skills for This Role

Risk ManagementSystems EngineeringISO 14971ISO 11608IEC 60601‐1TurboAC

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