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Risk Management Specialist
1 month ago
Best Buy Health is seeking a highly skilled Risk Manager to lead and maintain the risk management process for our health technologies. The successful candidate will be responsible for ensuring compliance with ISO 14971:2019 and other applicable standards and regulations.
Key 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.
- Bachelor's degree in a science, engineering, or related field required.
- Minimum of 5 years of experience in risk management required.
- 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, FDA QSR 820, and IEC 60601 preferred.
- Familiarity with software development methodologies (e.g., Agile, Waterfall) preferred.
- Comprehensive benefits including tuition reimbursement, caregiver support, and more.
- Generous Best Buy employee discount.
- Physical and mental well-being support via Best Buy Health Wellness Program.
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.
