Risk Management (Medical Devices)

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Quick Summary

Key Responsibilities

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 ,

Requirements Summary

ISO 14971 ISO 11608 IEC 60601‑1 and related standards Experience with TurboAC or risk management platforms is a strong plus.

Technical Tools

OtherHealthcareRisk Management

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.

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.

Responsibilities

~1 min read

→ 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.

Requirements

~1 min read

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

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

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.

On-site presence required in Indianapolis.

ALTEN Technology is an Equal Opportunity Employer. Our Policy is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual’s age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status.

Please beware of job seeker scams and see this important notice on our careers page for more information about our recruiting process.

Compliance Notice: 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.

Drug Screening Requirement: As a federal contractor, Alten USA maintains a drug-free workplace. All candidates selected for employment will be required to successfully complete a pre-employment drug screening as a condition of hire.