BD is looking to solve the problem of ensuring compliance with risk management requirements throughout all phases of the life cycle of its dispensing medical devices and solutions, while prioritizing patient safety and innovation.
Requirements
- Familiarity with risk management activities that support BD's compliance with various international regulatory bodies, including ISO 14971 and ISO 13485.
- Experience in medical device and/or regulated industry (required).
- Experience with remediation efforts and SHA, FMEA process implementation with medical devices is a plus.
- Ability to analyze data from BD’s proprietary sources to calculate risk probabilities and levels effectively.
- Technical experience with Pyxis or automated dispensing cabinets (preferred).
- Knowledge of IEC 60601 and IEC 62304 (a plus).
- Experience with quality certifications relevant to BD, such as ASQ Certified Quality Engineering, Certified Auditor, and Six Sigma credentials (preferred)
Responsibilities
- Lead cross functional discussions to ensure that all hazards associated with products are identified, risks are estimated, evaluated, controlled, and documented.
- Develop, maintain, and execute comprehensive risk management files, including but not limited to: Risk Management Plan, Risk Management Report, Risk Reviews, System Hazard Analysis (SHA), Hazard and Harm Analysis (HHA), Design FMEA (dFMEA), Process FMEA (pFMEA), Use FMEA (uFMEA).
- Drive implementation and validation of risk controls throughout the product lifecycle.
- Lead periodic risk reviews and ensure documentation aligns with BD’s quality systems.
- Develop, maintain and execute risk management plans that support product development and ongoing sustaining activities in accordance with BD’s risk management framework.
- Lead periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and document decisions and actions taken, aligned with BD’s quality systems and ensuring compliance with regulatory standards and practices.
- Lead remediation efforts for updating risk management documents and the implementation of the FMEA process.
Other
- Minimum 8 years within the medical device, bio-pharmaceutical, or biotechnology sectors
- Minimum 5 years leading and applying risk management concepts specifically within the context of medical devices ensuring high standards of patient and customer safety.
- Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline), preferred.
- Strong communication skills to relay department and area issues, ensuring clarity and cooperation across BD’s global functional teams.
- Ability to work on-site at least 4 days a week, with some flexibility for remote work
