Risk Management Project Engineer
Location:
Indianapolis, Indiana
About the Role:
Are you passionate about improving risk management processes and supporting medical device development?
Do you enjoy collaborating with cross‑functional engineering teams and becoming the go‑to expert on specialized software systems?
Join us as a Risk Management Project Engineer, where you'll support the development, migration, and continuous improvement of risk management deliverables.This role plays a key part in transitioning FMEAs into the Turbo AC Software System while driving consistency, accuracy, and compliance across engineering, manufacturing, quality, and human factors teams.
Responsibilities
- Support the development and deployment of risk management documentation aligned with ISO 14971
- Serve as the subject matter expert for the Turbo AC Software System
- Facilitate and author the migration of FMEAs from legacy software into Turbo AC
- Conduct working sessions to guide engineering and quality teams on Turbo AC usage
- Document system bugs, usability gaps, and enhancement opportunities for Turbo AC developers
- Create and execute test scripts to support Turbo AC upgrade validation
- Collaborate with Systems Engineering, Manufacturing, Human Factors, Mechanical Design, and Quality
- Create or update standard operating procedures (SOPs) to reflect best practices
- Support continuous improvement initiatives across risk management processes
Qualifications
- Bachelor's degree in Engineering, Biomedical, Systems, or related field
- 1-3 years of experience in medical device development or risk management
- Knowledge of ISO 14971 standards
- Experience creating and reviewing FMEAs and risk analysis tools
- Strong communication and organizational skills in cross‑functional environments
- Proficiency with Microsoft Excel, PowerPoint, and workflow documentation
Required Skills
- Understanding of risk management processes and documentation
- Experience with FMEAs or similar risk tools
- Ability to learn and support specialized software systems
- Strong problem‑solving and analytical skills
- Clear, organized communication across technical teams
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
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That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
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