Systems & Risk Management Engineer (Medical Device)

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.

Position Summary

We are seeking a Senior Risk Management Systems Engineer with deep expertise in medical device risk management and systems engineering to support a critical medical device development program. This individual will serve as a technical Subject Matter Expert (SME), leading the development, review, and assessment of risk management deliverables while ensuring compliance with applicable regulatory and industry standards.

The ideal candidate will have extensive experience in risk analysis, hazard assessment, functional safety, and systems engineering within the medical device industry. Experience with TurboAC or similar risk management platforms is highly desirable.

Key Responsibilities

Risk Management & Technical Assessment

• Lead the development, review, and technical assessment of key risk management deliverables throughout the product development lifecycle.
• Conduct technical reviews of the Preliminary Hazard Analysis (PHA).
• Support the development and review of:
• Benefit-Risk Clinical Hazard Analysis (BE CT CHA)
• Platform Clinical Hazard Analysis (Platform CHA)
• Platform Risk Libraries
• Ensure consistency and alignment between Risk Control Measures (RCMs), systems engineering deliverables, and design inputs.
• Verify compliance of hazards, risks, and RCMs with applicable standards, including:
• ISO 14971
• ISO 11608
• IEC 60601-1 and related standards
• Support integration and maintenance of platform risk libraries.

Risk Analysis & Documentation

• Contribute to the development and review of the Platform Risk Management Plan (RMP).
• Participate in Functional Failure Analysis (FFA), including:
• Identification of system-level failure effects
• Defect classification
• Risk evaluation and mitigation recommendations
• Support the preparation and maintenance of additional risk management documentation throughout the project lifecycle.

FMEA & Risk Tool Support

• Review and restructure existing Failure Modes and Effects Analyses (FMEAs) currently maintained in Microsoft Excel.
• Prepare and format FMEA data for migration into TurboAC, the client's risk management platform.
• Support the data import process and validate data integrity.
• Assist with establishing traceability and manual linkage between hazards, risk controls, and FMEAs following migration.

Required Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 8 years of experience in medical device risk management.
• Strong background in Systems Engineering and product development.
• Demonstrated expertise with:
• ISO 14971
• ISO 11608
• IEC 60601-1 and related standards
• Experience performing hazard analysis, risk assessments, and functional failure analysis.
• Experience developing and reviewing risk management documentation for regulated medical devices.
• Experience with TurboAC or similar risk management and requirements management platforms is highly preferred.

Preferred Qualifications

• Experience supporting complex medical device development programs.
• Familiarity with systems engineering lifecycle processes.
• Experience collaborating across Quality, Systems Engineering, Design Engineering, and Platform Engineering organizations.
• Knowledge of risk traceability and requirements management tools.

Professional Skills

• Strong analytical and problem-solving skills.
• Excellent technical writing and documentation abilities.
• Exceptional attention to detail.
• Ability to communicate complex technical concepts to cross-functional stakeholders.
• Demonstrated ability to work collaboratively in a multidisciplinary engineering environment.

Work Location

• On-site in Indianapolis, Indiana.

Work Authorization

• 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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