Best Buy · 3 hours ago

Risk Manager

New York, NY

Full-time

Remote

Senior Level

5+ years exp

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Responsibilities

Lead the risk management process, ensuring all phases of product development consider potential risks.

Identify potential hazards associated with both hardware and software components of medical devices.

Perform risk analyses using FMEA (Failure Mode and Effect Analysis) and other tools to assess the severity, likelihood, and overall risk of identified hazards.

Develop and implement risk control strategies to mitigate identified risks.

Document all risk management activities thoroughly, including assessments, control plans, and residual risk justifications.

Stay current with best practices and regulatory updates in medical device risk management.

Support regulatory audits and inspections related to risk management.

Qualification

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Risk ManagementISO 14971 2019FMEAMedical Device RegulationsISO 13485 2016FDA QSR 820IEC 60601Software Development MethodologiesAgileWaterfallMaster's Degree

Required

Bachelor’s degree in a science, engineering or related field required

Minimum of 5 years of experience in risk management required

Preferred

Master's degree in a relevant field (risk management, safety engineering) preferred

Minimum of 3 years of experience in risk management for medical devices, with experience in both hardware and software development preferred

Proven understanding of risk management principles and practices for medical devices in accordance with applicable standards and regulations such as: ISO 14971:2019, ISO 13485:2016 and FDA QSR 820 and IEC 60601 preferred

Familiarity with software development methodologies (e.g., Agile, Waterfall) preferred