Risk Management Specialist

Indianapolis, Indiana, United States. Posted 7 months ago

The role

The consultant will support the development, review, and technical assessment of key risk management deliverables for a medical device program. This includes conducting technical reviews and supporting integration activities related to platform risk libraries.

What you will do

Conduct the technical review of the PHA
Support the development and technical review of the BE CT CHA and platform CHA
Ensure alignment with Systems Engineering deliverables
Verify alignment of risks and RCMs with applicable standards
Support integration activities related to platform risk libraries
Contribute to the development and review of the Platform Risk Management Plan (RMP)
Participate in Functional Failure Analysis
Reviewing and structuring existing FMEAs currently in Excel
Reformatting data for integration into Turbo AC
Assisting with manual linking between hazards and FMEAs

Required qualifications

8+ years of experience in Risk Management for medical devices
Strong background in Systems Engineering methodologies
Expertise with ISO 14971
Expertise with ISO 11608
Expertise with IEC 60601-1 and related standards
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

Nice to have

Experience with TurboAC or risk management platforms

Benefits

Mentorship
Career growth opportunities
Comprehensive benefits

Before you apply

Only candidates who are U.S. Citizens or U.S. Permanent Residents (Green Card holders) are eligible
All candidates selected will be required to successfully complete a pre-employment drug screening

About the company

ALTEN Technology USA is an engineering company with 3,000+ experts across North America. It is part of the global ALTEN Group which has 57,000+ engineers in 30 countries.