Offer summary

Qualifications:

Bachelor’s degree in a science, engineering or related field required., Minimum of 5 years of experience in risk management required., Proven understanding of risk management principles and practices for medical devices in accordance with applicable standards and regulations., Master's degree in a relevant field and experience in medical devices preferred..

Key responsabilities:

Lead the risk management process throughout the product development lifecycle.

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

Perform risk analyses using FMEA and other tools to assess risks.

Develop and implement risk control strategies and document all risk management activities.

Job description

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 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 but may involve occasional onsite collaboration at our Best Buy Health hub. For this role, you must be located within a commutable distance to either the Boston MA, Minneapolis MN or San Antonio TX office. Current Best Buy Health and Best Buy employees are encouraged to apply, regardless of location. The recruiter or hiring manager will provide more details during the hiring process.

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
For this role, you must be located within a commutable distance to either the Boston MA, Minneapolis MN or San Antonio TX office. Current Best Buy Health and Best Buy employees are eligible regardless of location

Preferred Qualifications

Master's degree in a relevant field (risk management, safety engineering) preferred
Minimum of 3 years of experience in risk management for medical devices, systems and networks, 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 , of ISO 13485:2016 and FDA QSR 820 and IEC 60601 preferred
Familiarity with software development methodologies (e.g., Agile, Waterfall) preferred.

What’s In It For You

We’re committed to helping our people thrive at work and at home. We offer generous benefits that address your total well-being and provide support as you need it, especially key moments in your life.

Our Benefits Include

Physical and mental well-being support via Best Buy Health Wellness Program
Comprehensive benefits including tuition reimbursement, caregiver support, and more
Generous Best Buy employee discount

Best Buy Health is an Equal Opportunity Employer that complies with Section 503 of the Rehabilitation Act and Vietnam Era Veterans' Readjustment Assistance Act (VEVRAA). We are committed to equal employment opportunity for all applicants and employees. Learn more about our commitment HERE.

Reasonable Accommodation

Best Buy Health will make reasonable accommodations for employees and applicants for their religious beliefs and practices, mental or physical disabilities, and pregnancy, childbirth, and related conditions, and otherwise as required by applicable law. If you need a reasonable accommodation in the application process - to access job postings, to apply for a job, for a job interview, for pre-employment processes or with the onboarding process - please contact Talent Acquisition at talent.acquisition@bestbuy.com.

To learn more, view the “Know Your Rights” poster HERE.

Position Type: Full timePandoLogic. Keywords: Risk Manager, Location: Boston, MA - 02108

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