To ensure a rapid processing of your application, please apply only via the u201cApplyu201d button. Please include a letter of motivation and a current resume with your application. _About the Job_ You serve as a crucial member of the Global Device Platform Engineering Team, taking responsibility for ensuring robust device design and successful delivery of Drug Device Combination Products and Medical Devices. Working within strict technical, scientific, and regulatory frameworks, you manage development projects to meet established timelines and budgets. You provide technical leadership and coordination while collaborating closely with cross-functional teams and interacting with Global Device / Quality Leadership Teams and other senior leaders. You also contribute expertise to optimize the device design for manufacturing efficiency and user experience, while responding to market trends or new standards requirements. Your specialized knowledge in Autoinjector Platform Design and Evaluation supports both - new product development and lifecycle management of marketed products. Through active participation in the Design Control Process, you maintain essential relationships with both - internal departments and external stakeholders to ensure overall product success. We look forward to your application! Responsibilities Development of Drug Device Combination Products and Medical Devices following regulatory requirements (FDA, EU MDR) and standards (ISO, IEC) Act as a systems engineer for both new Drug Device Combination Product development and enhancement of existing platforms. Ensures seamless integration of all product elements including drug formulation, primary container, delivery device, manufacturing processes, testing, labelling and packaging solutions Provide technical leadership to interdisciplinary teams (Design, Quality, Process Engineers, Manufacturing, etc.) and coordinates technical tasks with project / product core teams Create & maintain Autoinjector Technology Platform & Design documentation (design requirements, dFMEA, CAD data, technical specifications, etc.) Plan and maintain Design Verification activities and documentation (incl. evaluation and interpretation of test results) Maintain the design of Drug Device Combination Products and Medical Devices in life-cycle management Contribute to Change Control and Event processes as Autoinjector Platform / Device Design Expert _About you_ Education & Experience University / Master / Bacheloru00b4s degree as an engineer with focus on mechanical engineering, plastics engineering, medical engineering or similar A wide range of years of professional working experience in Drug Device Combination Product Development or Medical Devices, industrialization or manufacturing Experience in leading of development projects and technical management of interdisciplinary development teams Several years of experience with regulatory agencies (e.g. EMA, FDA or TUEV) and key regulatory requirements in the industry (such as DIN and ISO) Experienced and qualified in project management activities (e.g. PMP) Soft skills Confident attitude, committed and used to working independently Excellent contacting and teamworking skills Languages Proficient English (written & speaking) is required German is beneficial _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 itu2019s through a promotion or lateral move, at home or internationally. Benefit from a well-thought-out benefits package that rewards your contribution and commitment. We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits. Pursue _Progress_. Discover _Extraordinary_. Progress doesnu2019t happen without people u2013 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Letu2019s pursue progress. And letu2019s discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! \Sanofi (https://www.linkedin.com/feed/hashtag/?keywords=sanofi&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7227338801126264833) \SanofiCareers \PursueProgress (https://www.linkedin.com/feed/hashtag/?keywords=pursueprogress&highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7209134303526436865) Pursue _progress_, discover _extraordinary_ Better is out there. Better medications, better outcomes, better science. But progress doesnu2019t happen without people u2013 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, letu2019s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)