Job Description: Summary
Staff Quality Risk Management Engineer who is responsible for leading Human Factors/Usability Risk Management activities. This position will work closely with cross-functional development teams to define the risk management strategy, processes and deliverables for human factors and usability engineering throughout the design, development, and Life Cycle Management process across BD/CareFusion products. S/he will infuse a risk-based approach throughout development phases of infusion pumps and supporting products, and facilitate the usability risk management deliverables to support regulatory filing, product launch, and post-market surveillance. S/he will provide subject matter expertise in HF/UE activities including integration of known and foreseeable use, preliminary HF analysis, task analysis, use-related risk analysis and facilitating creation and maintenance of Usability Engineering Files.
Primary responsibilities include but are not limited to:
Work collaboratively with engineering, design, commercial, and product teams to identify critical tasks and help implement user requirements into products, to create user interface (UI) requirements, that meet the needs of users and enrich the overall user experience across infusion pumps portfolio or programs.
Apply systematic risk-based process including identifying potential use-related hazards, mitigating those risks, and validating the risk mitigations are effective.
Collaborate cross-functionally build and maintain use related risk analyses to ensure that all use-related risks have been mitigated and reduced to an acceptable level.
Support and provide HFE expertise preparation for clinical studies and regulatory submissions in accordance with HF best practices, guidance and standards.
Analyze objective and subjective data from usability studies to inform design, inform risk minimization, and provide alternative solutions.
Integrating known and foreseeable use issues, analyzing human factors data, supporting root cause analysis activities, evaluating use related risk and supporting submissions.
Analyze complaints from on-market products for usability-related issues.
Prepare documentation to support development activities, design controls, DHF including task analysis, risk assessment, and supporting documentation for regulatory submissions.
Actively communicate with internal and external key stakeholders.
Electrical/mechanical/software Medical Device or infusion pump product experience
Advanced knowledge of risk management, regulatory, quality and human factors engineering polices, principles and best practices
Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including: ISO 14971, ISO 13485, IEC 62366, 21 CFR 820.30, HE 75, Human Factors Studies and FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices, interoperability, assurance cases ,General Device Labeling
21 CFR Part 801, Use of Symbols
21 CFR Part 801.15,
The position requires strong oral and written communication and organizational skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products.
Leadership or supervisory experience is preferred
Primary Work Location
USA CA - San Diego TC Bldg C&D
BD (Becton, Dickinson And Company)