Digital Device Quality Engineering Lead

Job Title: Digital Device Quality Engineering Lead

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:

• Manage external suppliers throughout the product lifecycle, including evaluating and qualifying suppliers, monitoring supplier performance, auditing supplier's quality management system to applicable regulations and quality standards, providing metrics, and addressing quality and regulatory issues.

• Author and maintain quality agreements

Audits and Inspections:

• Collaborate with Business Product owners, Quality and Digital teams to prepare for regulatory inspections and internal audits, respond to questions and address findings through corrective/preventive action plans to improve compliance and effectiveness of the quality management system

About You

KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS

Minimum:

• Bachelor’s degree in a relevant field, such as engineering or life sciences.

• 4+ years’ experience in medical device product development (Design Control) focused on quality engineering and quality system related activities.

• Relevant experience in risk management for medical devices.

• Good knowledge of Quality System standards and regulations including 21 CFR 820, ISO 13485, IEC 62304 and ISO 14971.

• Language - Business fluent (written and oral) in English is required

Preferred:

• Master’s degree in engineering or life sciences (e.g. software engineering, systems engineering, electrical engineering, or related engineering degree).

• Strong leadership, communication and presentation skills, to inform and persuade both in speaking and in writing.

• Ability to learn quickly and self-educate on different technologies/therapies as applicable to medical products and procedures (Self-starter attitude)

• A general understanding of the potential sources of risk providing solutions and how to manage them.

• 1 -2 years of supplier management experience preferred.

• Knowledge of and experience in performing safety and cybersecurity risk management for medical devices

• Ability to enter into highly different cultural and regulatory backgrounds worldwide with diplomatic sensitivity’

• Experience in Agile development principles and can work with at least one of the common frameworks

• The ideal applicant will have experience in at least one or more of the following technical domains:

• • Medical devices and systems

  • Mobile device application architecture and security

  • IoT (embedded) devices and systems

  • Cloud systems architecture and security

  • Large-scale application architecture and security

  • Data protection architectures for data at rest and in transit

  • AI and machine learning concepts

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.