Post-Market Risk Management Manager

Becton Dickinson Medical Devices • San Diego, CA

2d • $126,600 - $208,900 • Onsite

About The Position

The Post Market Risk Manager is responsible for implementing and ensuring compliance with design control and risk management requirements throughout all phases of the life cycle of BD's dispensing medical devices and solutions. This role involves leading cross-functional teams during design, development, and post-market risk management reviews to ensure all necessary risk management activities align with the quality system. The manager will lead and coach cross-functional teams on risk management processes, applying a risk-based approach throughout development phases, and facilitating risk management deliverables to support regulatory filings, product launch, and post-market surveillance risk management framework. The position emphasizes BD's commitment to innovation and patient safety.

Requirements

• Bachelor’s degree in engineering
• 5 years of Quality, Design Controls, Risk Management experience within the medical device industry.
• Minimum of 5 years of Post-Market Quality, specifically complaint trending/data analytics and risk assessments.
• Two years of people management experience.
• Advanced knowledge of risk management, design controls, regulatory, quality engineering policies, principles and standard methodologies.
• Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including ISO 14971, ISO 13485, FDA 21 CFR 820.
• Strong oral and written communication and interpersonal skills.
• Technical problem solving skills.
• Ability to work in teams.
• Critical thinking.
• Ability to adapt to a rapidly changing environment.
• Desire to contribute to meaningful and innovative products.

Responsibilities

• Implement and ensure compliance with design control and risk management requirements throughout all phases of the life cycle of BD's dispensing medical devices and solutions.
• Lead cross-functional teams during the design and development and post-market risk management reviews to ensure that all necessary risk management activities are carried out in accordance with the quality system.
• Lead and coach cross functional teams on risk management processes that support BD's commitment to innovation and patient safety.
• Apply a risk-based approach throughout the development phases and facilitate the risk management deliverables to support regulatory filings, product launch, and post-market surveillance risk management framework.
• Lead multi-functional discussions such as with engineering, design, commercial, and product teams to ensure that all hazards associated with products are identified, risks are estimated, evaluated, controlled, and documented.
• Monitor that risk controls are implemented, verified, and validated for products in development and verify the effectiveness of risk control measures throughout the product life cycle.
• Maintain ISO 14971 compliant risk management files.
• Serve as a subject matter expert in design control and post-market risk management process and execution.
• Collaborate on design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements.
• Lead remediation efforts for updating risk management documents and the implementation of the FMEA process.
• Perform and document Risk Management Reviews to communicate results of the risk management process to cross-functional teams.
• Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members.
• Identify opportunities for continuous improvement of the Risk Management Process.
• Facilitate and provide ongoing training on standards/processes as needed for other associates or functions.
• Assist with strategic initiatives and planning.
• Mentor and coach post-market risk management and cross functional teams on risk management processes.

Benefits

• Comprehensive Total Rewards program
• Reward and recognition opportunities that promote a performance-based culture
• Competitive package of compensation and benefits programs

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees