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About The Job
You serve as a crucial member of the GDPU Device Platform engineering team, taking responsibility for ensuring robust device design and successful delivery of 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 GDPU / GDPQ Leadership Team 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 medical devices and drug device combination products 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
* Maintain the design of medical devices and drug device combination products in life-cycle management
* Provide technical leadership to interdisciplinary teams (Design, Quality, Process Engineers, etc.) and coordinates technical tasks with project / product core teams
* Create and maintain Autoinjector platform & device design documentation (CAD data, dFMEA, technical specifications, etc.)
* Plan and maintain design verification activities and documentation (incl. evaluation and interpretation of test results)
* Contribute to change control and event processes as Autoinjector platform /device design expert
About You
Education & Experience
* University / Master / Bachelor´s 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 medical device or combination product development, 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 it’s 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 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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
#Sanofi
#SanofiCareers
#PursueProgress
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Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering and Information Technology
* Industries
Pharmaceutical Manufacturing
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