Digital Device Quality Engineering Lead

Job Title: Digital Device Quality Engineering Lead

Location: Cambridge, MA

About the Job

At Sanofi, we’re committed to providing the next-gen healthcare that patients and customers need. It’s about harnessing data insights and leveraging AI responsibly to search deeper and solve sooner than ever before.

Our team has released an FDA certified class II medical device titration application. We are gearing up for other software applications across the diabetes and speciality care journey, with external LMR partnerships.

Join our Global Digital Team as a Digital Device Quality Engineering Lead. You will be responsible for the quality assurance efforts for our Software as Medical Device (SaMD) products, ensuring that they meet the highest standards of quality, safety, and efficacy. Your role involves driving quality strategy in various therapeutic areas and markets. Accountable for the Software Quality Engineering, Risk Management and Supplier Control support of SaMD’s by leading all cGMP compliance activi-ties, as well as compliance with relevant domestic and international regulations, standards and guide-lines and customer requirements. The position contributes directly to meeting regulatory submission and launch timelines of the software as medical devices products.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Relationship Management with Stakeholders, Ensure Quality & Compliance of SaMD Products:

• Represent Digital Device Quality Engineering on cross-functional teams and lead quality planning activities.

• Plan for and provide appropriate Quality & Compliance support for the project and application portfolios of the SaMD Digital Patient Experience teams

• Lead quality engineering support for design and development, and facilitate the application of controls and risk management to ensure that SaMD’s are designed to be safe, effective and in compliance with the applicable regulations worldwide

• Collaborate and mentor cross-functional teams in the development of design & development plans, requirements, specification development, engineering studies, design verification protocols and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.

• Lead and participate in design reviews

• Provide Quality impact assessment for product changes

• Provide quality input into CAPA and nonconforming product investigations

• Support root cause investigations and implementation of corrective actions

• Drive continuous improvement and improve processes and procedures to enhance product quality and increase efficiency.

• Promote quality and compliance throughout the Product life cycle and implement processes, procedures, lead awareness and training on Quality Management System

Risk Management:

• Lead all risk management activities (risk management plan, FMEA’s, risk management report) according to ISO 14971 and TIR 57

• Plan, prepare and perform risk management activities for medical devices according to project phases following all relevant internal procedures, processes and external requirements for development products.

• Ensure that all hazards, threats and vulnerabilities associated with a medical device are identified, the associated risks are estimated and evaluated and that these risks are controlled; monitors that these risk controls are implemented, verified and validated.

• Maintain a close link to the human factors engineering process to meet the needs and ensure the safety of all users and patients.

Supplier Quality: