Risk Management Specialist

We’re ALTEN Technology USA, an engineering company that provides solutions for engineering, technology, and product development projects. For decades, we’ve been helping our clients develop products that are changing the world, whether that’s by shaping the future of space exploration, saving lives with medical devices that set a new standard of care, or creating the fully autonomous electric taxi of tomorrow. Our team of more than 600 people works across industries including aerospace, medical devices and life sciences, unmanned systems and robotics, automotive OEM and tier 1 suppliers, commercial vehicle, electric vehicles, rail, and more. Our offices across the US have different industry focuses and engage with our clients in different ways, ranging from working on-site at client facilities to performing product development at our delivery centers.

ALTEN Group, our parent company, has been a leader in engineering and information technology for more than 30 years. ALTEN Group operates in 30 countries across Europe, North America, Asia, Africa and the Middle East and employs more than 36,000 people, 88% of whom are engineers. The company covers the whole development cycle and offers a choice of service levels, from technology consulting to complete project outsourcing.

When you join ALTEN Technology USA, you join a group of people passionate about collaborating to solve some of the world’s most technical engineering challenges. Our success is tied to taking care of our employees by building relationships and providing opportunities for mentorship and career growth. We offer comprehensive benefits for all full-time employees, including medical, dental, and vision insurance; a 401(k) plan with employer matching; paid time off (PTO); paid parental leave; and mentorship to help you take your career to the next level. You don’t have to take our word for it that we are a great place to work—we were named on the 2023 Top Workplaces list thanks to feedback from our proud employees.

Role Overview

• 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.

Key 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.
• 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
• Assisting with manual linking between hazards and FMEAs once uploaded

Required Qualifications / Technical Competencies

• 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.

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) or remote.

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.

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.

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