CPS Recruitment is seeking an experienced Risk Manager for a leading medical device provider specializing in patient monitoring systems. This role focuses on managing risk throughout the product lifecycle, ensuring compliance with ISO 14971:2019 standards, and collaborating with cross-functional teams.
This is a long-term contract position. You must be eligible for employment in the United States without restriction!
Key Responsibilities:
Develop and execute risk management plans for product development and sustaining activities.
Ensure compliance with regulatory standards, particularly ISO 14971:2019.
Lead cross-functional risk management reviews and collaborate with Quality, Systems/Risk, Project Management, Regulatory Affairs, and Marketing teams.
Conduct risk assessments, identify potential hazards, and ensure traceability from stakeholder needs to design outputs.
Oversee operational risk management activities and ensure compliance with company policies and procedures.
Qualifications:
Bachelor's degree in Engineering, Quality Management, Risk Management, or a related field (advanced degrees or certifications are a plus).
At least five years of risk management experience in the medical device industry, preferably in patient monitoring systems.
Strong understanding of stakeholder requirements, design inputs/outputs, and hazardous situation analysis.
Experience with Systems Engineering-driven processes for ISO 14971 compliance.
Excellent analytical, problem-solving, and communication skills with the ability to engage cross-functional teams.
Why Apply?
Competitive compensation and comprehensive benefits.
Opportunities for professional growth in an innovative and collaborative work environment.
Apply now! Submit your resume to cnyjobs@cpsrecruiter.com for immediate consideration.