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
- 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
- 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 , 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
About us Best Buy Health aims to enrich and save lives through technology and meaningful connections. Our strategy focuses on three main areas: consumer health products that help customers live healthier lives, device-based emergency response services for the active aging population, and virtual care offerings that help to connect patients and physicians.
Best Buy Health is an Affirmative Action and Equal Opportunity Employer dedicated to creating an inclusive environment that values the diversity of our employees and does not discriminate against any employee or applicant. We are committed to equal employment opportunity for all applicants and employees, without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, gender identity, genetic information, or any other protected characteristic under applicable law. Learn more about our Affirmative Action Policy Statement 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. 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 testing or with the onboarding process - please contact Talent Acquisition at talent.acquisition@bestbuy.com.
To learn more about, view the “Know Your Rights” poster and Pay Transparency Nondiscrimination Provision HERE.
Position Type: Full time
