ALTEN Technology USA

ALTEN Technology USA

Risk Management (Medical Devices)

Indianapolis, Indiana, United States · Contract

Work authorization requiredDetected 16 days ago
ExcelSystems EngineeringRoboticsMedical DevicesMentoring

About the role

  • We are seeking a Risk Management Subject Matter Expert (SME) with extensive experience in medical device risk management and a solid background in Systems Engineering.

Responsibilities

  • 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).
  • Support integration activities related to platform risk libraries.
  • Support for Additional Risk Management Deliverables

Requirements

  • All candidates selected for employment will be required to successfully complete a pre-employment drug screening as a condition of hire.

Nice to have

  • Verify alignment of risks and RCMs with applicable standards (e.g., ISO 11608, IEC 60601‑1, etc.).
  • Contribute to the development and review of the Platform Risk Management Plan (RMP).
  • Identification of system-level effects.
  • Assignment of appropriate defect classifications.
  • Support additional Risk Management deliverables as required throughout the project lifecycle.
  • Reviewing and structuring existing FMEAs currently in Excel
  • Reformatting data so it can be integrated into Turbo AC (their risk management tool)
  • Supporting the upcoming import process and ensuring everything is properly structured

Company info

  • Alten USA is a federal contractor subject to the requirements of the Vietnam Era Veterans' Readjustment Assistance Act (VEVRAA) and Executive Order 11246.
  • We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Equal opportunity

  • All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age, genetic information, or pregnancy.
  • Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Visa & Work Authorization

  • Work Authorization Requirement: Due to client requirements, only candidates who are U.S. Citizens or U.S. Permanent Residents (Green Card holders) are eligible for consideration for this position.
Apply directly at ALTEN Technology USA →Create a free account for alerts like thisView ALTEN Technology USA immigration profile

This listing is sourced directly from ALTEN Technology USA's careers page and normalized into a canonical job model.