Job Title: Principal Device Leader

Bridgewater, NJ or Cambridge, MA

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Principal Device Leader within our Sanofi`s Global Device and Packaging Unit, will be to be fully accountable for concurrently developing multiple combination products with low-to-medium technical maturity and high complexity, spanning from the Target Device Profile to launch readiness. This includes project scoping and budget development; key-stake holder management, project planning and scheduling; coordinating and monitoring the work of internal and external teams.

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:

  • As Principal Device Leader you will play a pivotal role in leading the development of our products including primary packaging, devices, and packaging. Leadership of multiple, concurrent projects, with significant complexity, size, scope, budget and relying on major partnership(s) is typical for this role.

  • You will lead the cross-functional Device Project Core-Team and external partners assigned to the project to develop a robust device project strategy addressing essential aspects of product and process engineering, project management, quality (this includes establishment of a Design History File according to 21CFR820 and ISO13485 as needed etc.) and regulatory.

  • You will partner directly with the Global Project Head, business, Chemistry, Manufacturing and Control (CMC) key stakeholders, suppliers and within Manufacturing and Supply (M&S) to ensure robust and aligned clinical, marketing, and regulatory strategies.

  • You will represent GDPU for the project in all cross-functional meetings and ensure that strategy, scope, plan, and budget, is fully understood by all stakeholders and aligned in advance of governance body meetings. For projects for which the device component is core, represent GDPU directly, ensuring that device aspects are covered explicitly into a specific section.

About you

  • Advanced degree in Science or Engineering (mechanical, electromechanical, medical technology, plastics, physics, or related field).

  • Professional working experience in medical device or combination product development, industrialization or manufacturing

  • Demonstrated leadership experience in managing cross-functional teams in bringing medical devices and combination products from concept to commercialization.

  • Experience with establishing and managing of activities at third party manufacturers, vendors and/or with partnerships in a global environment is required.

  • A track record of solving complex technical challenges in medical device projects to drive business impact and growth.

  • Solid knowledge of key regulatory requirements and experience working with regulatory agencies or notified bodies (e.g., FDA, EMA or TUEV).

  • Must be fluent in English. Basic knowledge of French or German is a plus.

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.

Learn more about Sanofi M&S: https://www.youtube.com/watch?v=_xz_sSanXhc

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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