Manager, Risk Management

GROW WITH US:

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take a “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME:

Tandem Diabetes Care is proud to manufacture and sell the t:slim X2 insulin pump with Control-IQ technology. We’re also so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Since many of our own team members live with type 1 diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com.

A DAY IN THE LIFE:

Responsible for the implementation and compliance of risk management requirements throughout all phases of the life cycle of Tandem’s medical devices. This includes but is not limited to risks associated with medical devices, such as risk related to biocompatibility, data and systems security, electricity, moving parts and usability. Will lead, coach and develop a risk management team that supports R&D, production and post market surveillance activities.

• Establish, document, implement, maintain and improve processes for: identifying hazards and hazardous situations associated with Tandem’s products, estimate and evaluate the associated risks, controlling these risks, and monitoring the effectiveness of the risk control measures throughout the product life cycle.
• Lead the review of the suitability of the risk management process at planned intervals to ensure continuing effectiveness of the risk management process and document decisions and actions taken.
• Initiate and maintain the suitability of risk management files for Tandem’s products.
• Develop and maintain risk management plans to support product development and sustaining activities in accordance with the risk management process.
• Perform risk analysis for Tandem’s products and implement risk analysis activities and document results in the risk management file.
• Based on the outcome of the risk analysis, evaluate the estimated risk and acceptability of each risk, using the risk acceptance criteria per Tandem’s Quality System. If risk is not acceptable, lead the activities to identify and document risk control methods. Update risk acceptance criteria based on changes to intended use of any medical device.
• Support the Benefit-Risk Analysis process and lead the evaluation of the assessment of overall residual risk.
• Lead risk management review activities to ensure the risk management plan has been appropriately implemented, assessment of overall residual risk, and appropriate methods are in place to collect and review information in the production and post-product phases.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Lead production and post-production risk management activities.
• Manage, coach, and lead a risk management team to support Tandem’s Risk Management System. Prioritizes assigned responsibilities, review and modify plan as needed based on company objectives and priorities.
• Supports the short-term planning process for the department including headcount, budgeting, training, and systems requirements.
• Participates in the selection, development, performance appraisal, merit recommendation, and promotion of staff.
• Ensures department staff is properly trained, per designated training plan, before assuming job responsibilities.
• Develop, reviews, and update risk probability criteria as needed.
• Develops and manages schedules and performance requirements of staff.
• Coordinating cross functional teams in the development and implementation of control plans, i.e. dFMEA and pFMECA.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Performs other duties as assigned.

YOU’RE AWESOME AT:

• Bachelor of Science degree, preferably in engineering, biomedical sciences, clinical sciences or related discipline. Master’s degree is a plus.
• 8 years in a regulated industry, bio-pharmaceutical technology industry preferred.
• 5 years applying risk management concepts.
• 5 years prior experience leading/supervising a customer facing department and associated staff is preferred
• Supporting inspections from regulated bodies.
• Establishing and/or maintaining a risk management file.
• Using electronic document management systems t