Sanofi
Director of Connected Device Technology
Sanofi, Bridgewater, Massachusetts, us, 02324
Director of Digital Technologies
About the JobWe 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?About the RoleThe Director of Digital Technologies will be responsible for leading the design, development, and implementation of connected medical device technologies and ensuring they meet the specific needs of the pharmaceutical and drug-device combination products. The incumbent will collaborate with internal and external cross-functional teams to drive product development and ensure alignment with industry requirements. To be successful in this role, an ideal candidate will require a working knowledge and expertise in the broad spectrum of connected device development, including electronic hardware, firmware, and software, as well as a clear understanding of Quality and Regulatory requirements. The Director will be accountable for the risk assessments related to the design and functionality of connected technologies in devices and implementation of risk mitigation strategies as needed.In addition, it will be important to stay updated on the emerging technologies and industry trends related to connected medical devices and incorporate them into product development strategies. The Director will lead the development of prototypes and ensure rigorous testing to validate the performance and safety of connected technologies incorporated into the final combination products. He/She will also support GDPU and GDPQ Design Control Process and closely work and interact with the European Standards Organization. The Director will work closely with GDPU senior leadership, key representatives from the core device platforms and device manufacturing sites, Digital, Global Quality, GRA, and other key functions in M&S organization.Key Accountabilities:This position has a very strong influence on the company’s strategic growth, topline sales, and delivering novel therapies to a wide range of diseases. It is a global role, responsible for leading the development and implementation of digital technologies into the core Sanofi platforms (Safety Systems, Pens, Auto-injectors, LVD/OBDS), secondary packaging, and selected drug-device combination products.In this role, the Director will be responsible for:Leading the design, development, and implementation of connected & digital medical device technologies and ensuring they meet the specific needs of the pharmaceutical and drug-device combination products.Scouting connected technologies landscape to identify suitable options to support R&D and GBU portfolios.Supporting Lifecycle Management (LCM) of commercial products that contain connected technologies.Collaborating with cross-functional teams, including Digital, Quality Assurance, Regulatory Affairs, Global Business Units, and others, to drive product development and ensure alignment with industry requirements.Conducting or supporting risk assessments related to the design and functionality of connected technologies in devices and implementation of risk mitigation strategies as needed.Staying updated on emerging technologies and industry trends related to connected medical devices and incorporating them into product development strategies.Leading the development of connected technologies prototypes, their optimization, industrialization and scale-up, and ensuring rigorous testing to validate the performance and safety of connected technologies incorporated into the final combination products.Supporting GDPU and GDPQ Design Control Process and closely working and interacting with the European Standards Organization.Closely collaborating with GDPU senior leadership, key representatives from the core device platforms and device manufacturing sites, Digital, Global Quality, GRA, and other key functions in the M&S organization.In the future, the role may expand to the management of a small group of Design and Senior Design Engineers. In this expanded role, this incumbent will be responsible for defining and implementing a strategy for providing adequate skill sets to meet future needs of the development team. This includes actively directing, motivating, and developing individuals and their skills, so that the resource needs are met.About YouBasic Qualifications:Bachelor’s or Master’s degree in engineering or a related field.10 - 12 years of work experience in the area of connected & digital medical device technologies or equivalent.Proven experience in the development of connected & digital medical devices, preferably within the pharmaceutical and drug/device combination product industries.Experience with project management and the ability to lead cross-functional teams.Strong understanding of regulatory requirements, including FDA guidelines for medical devices.Knowledge of risk management and mitigation strategies in a regulated environment.Excellent presentation, problem-solving, and analytical skills.Proven experience in leadership, functional or disciplinary.Preferred Qualifications:Knowledge of risk management and mitigation strategies in a regulated environment.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.#GD-SA#LI-SA#LI-OnsitePursue
progress , discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, or gender identity.
#J-18808-Ljbffr
About the JobWe 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?About the RoleThe Director of Digital Technologies will be responsible for leading the design, development, and implementation of connected medical device technologies and ensuring they meet the specific needs of the pharmaceutical and drug-device combination products. The incumbent will collaborate with internal and external cross-functional teams to drive product development and ensure alignment with industry requirements. To be successful in this role, an ideal candidate will require a working knowledge and expertise in the broad spectrum of connected device development, including electronic hardware, firmware, and software, as well as a clear understanding of Quality and Regulatory requirements. The Director will be accountable for the risk assessments related to the design and functionality of connected technologies in devices and implementation of risk mitigation strategies as needed.In addition, it will be important to stay updated on the emerging technologies and industry trends related to connected medical devices and incorporate them into product development strategies. The Director will lead the development of prototypes and ensure rigorous testing to validate the performance and safety of connected technologies incorporated into the final combination products. He/She will also support GDPU and GDPQ Design Control Process and closely work and interact with the European Standards Organization. The Director will work closely with GDPU senior leadership, key representatives from the core device platforms and device manufacturing sites, Digital, Global Quality, GRA, and other key functions in M&S organization.Key Accountabilities:This position has a very strong influence on the company’s strategic growth, topline sales, and delivering novel therapies to a wide range of diseases. It is a global role, responsible for leading the development and implementation of digital technologies into the core Sanofi platforms (Safety Systems, Pens, Auto-injectors, LVD/OBDS), secondary packaging, and selected drug-device combination products.In this role, the Director will be responsible for:Leading the design, development, and implementation of connected & digital medical device technologies and ensuring they meet the specific needs of the pharmaceutical and drug-device combination products.Scouting connected technologies landscape to identify suitable options to support R&D and GBU portfolios.Supporting Lifecycle Management (LCM) of commercial products that contain connected technologies.Collaborating with cross-functional teams, including Digital, Quality Assurance, Regulatory Affairs, Global Business Units, and others, to drive product development and ensure alignment with industry requirements.Conducting or supporting risk assessments related to the design and functionality of connected technologies in devices and implementation of risk mitigation strategies as needed.Staying updated on emerging technologies and industry trends related to connected medical devices and incorporating them into product development strategies.Leading the development of connected technologies prototypes, their optimization, industrialization and scale-up, and ensuring rigorous testing to validate the performance and safety of connected technologies incorporated into the final combination products.Supporting GDPU and GDPQ Design Control Process and closely working and interacting with the European Standards Organization.Closely collaborating with GDPU senior leadership, key representatives from the core device platforms and device manufacturing sites, Digital, Global Quality, GRA, and other key functions in the M&S organization.In the future, the role may expand to the management of a small group of Design and Senior Design Engineers. In this expanded role, this incumbent will be responsible for defining and implementing a strategy for providing adequate skill sets to meet future needs of the development team. This includes actively directing, motivating, and developing individuals and their skills, so that the resource needs are met.About YouBasic Qualifications:Bachelor’s or Master’s degree in engineering or a related field.10 - 12 years of work experience in the area of connected & digital medical device technologies or equivalent.Proven experience in the development of connected & digital medical devices, preferably within the pharmaceutical and drug/device combination product industries.Experience with project management and the ability to lead cross-functional teams.Strong understanding of regulatory requirements, including FDA guidelines for medical devices.Knowledge of risk management and mitigation strategies in a regulated environment.Excellent presentation, problem-solving, and analytical skills.Proven experience in leadership, functional or disciplinary.Preferred Qualifications:Knowledge of risk management and mitigation strategies in a regulated environment.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.#GD-SA#LI-SA#LI-OnsitePursue
progress , discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, or gender identity.
#J-18808-Ljbffr