Risk Management (Medical Devices)

ALTEN Technology USA•Indianapolis, IN

15h•Onsite

About The Position

We’re ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life—from advancing space exploration and life-saving medical devices to building autonomous electric vehicles. With 3,000+ experts across North America, we partner with leading companies in aerospace, medical devices, robotics, automotive, commercial vehicles, EVs, rail, and more. As part of the global ALTEN Group—57,000+ engineers in 30 countries—we deliver across the entire product development cycle, from consulting to full project outsourcing. When you join ALTEN Technology USA, you’ll collaborate on some of the world’s toughest engineering challenges, supported by mentorship, career growth opportunities, and comprehensive benefits. We take pride in fostering a culture where employees feel valued, supported, and inspired to grow. Position Summary 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. The consultant will support the development, review, and technical assessment of key risk management deliverables for the medical device program.

Requirements

8+ years of experience in Risk Management for medical devices.
Strong background in Systems Engineering methodologies.
Expertise with key standards, including: ISO 14971, ISO 11608, 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, including Systems Engineering, Quality, Design, and Platform Engineering.

Nice To Haves

Experience with TurboAC or risk management platforms is a strong plus.

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.