Risk Manager - Best Buy Health
Boston, MA
About the Job
As the Risk Management and Safety Manager you will be responsible for leading and maintaining the risk management process through the product development lifecycle for Best Buy Health's health technologies ensuring compliance with ISO 14971:2019 and any other applicable standards and regulations. This will include initiating and managing product and process risk assessments, overseeing safety protocols, and ensuring compliance with regulations. This role is perfect for you if you are someone who is looking to leverage your in-depth knowledge of risk management to develop and implement risk control strategies that enhance the business's services, strategic goals, and objectives.
This role is remote, which means you would work virtually from home or another US-based non-Best Buy Health location.
What you'll do
This role is remote, which means you would work virtually from home or another US-based non-Best Buy Health location.
What you'll do
- 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.
Basic qualifications
- Bachelor's degree in a science, engineering or related field required
- Minimum of 5 years of experience in risk management required
Preferred qualifications
Source : Best Buy Health
