Job Description Summary

The Senior Quality Risk Management Engineer is responsible for planning, coordination and execution of Risk Management activities for products in design & development. This position will work closely with cross-functional development teams to create and execute the risk management strategy, processes and deliverables throughout the design and development process across BD products. They will apply a risk-based approach throughout development phases of infusion pumps and supporting products, and facilitate the risk management deliverables to support regulatory filings, product launch, and post-market surveillance risk management framework.

Job Description

Responsibilities

Primary responsibilities include but are not limited to:

·Collaborate with engineering, design, commercial, and product teams to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, controlled and documented; and monitors that the risk controls are implemented, verified, and validated for products in development.

·Plan and execute the management of risk for medical device projects to ensure that risk management is performed efficiently and in sufficient detail in support of new product development.

·Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams.

·Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members that share in varying pieces of the risk management lifecycle

·Identify opportunities for continuous improvement of the Risk Management Process

Basic Qualifications:

·Bachelor's degree in technical field and 3-5 years of Quality, Risk Management, or Human Factors Engineering experience within the medical device industry

·Electrical/mechanical/software Medical Device or infusion pump product experience

·Advanced knowledge of risk management, regulatory, quality and/or human factors engineering polices, principles and best practices

·Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including: ISO 14971, ISO 62304, TIR 57, IEC 62366, 21 CFR 820.30, HE 75, Human Factors FDA  Guidance:  Applying Human Factors and Usability Engineering to Medical Devices

·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

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift