Senior Device Design Engineer (all genders)

Sanofi; Frankfurt; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading company in the pharmaceutical industry is seeking an engineer to join their Global Device Platform Engineering Team in Frankfurt. The role involves overseeing the development of Drug Device Combination Products and ensuring compliance with regulatory standards. The ideal candidate should have a degree in engineering, substantial experience in device development, and excellent project management skills.

Leistungen

Wide range of health and social benefits

14-week paid family leave

Numerous prevention programs

Childcare benefits

Qualifikationen

• Wide range of years of professional experience in Drug Device Combination Product Development or Medical Devices.
• Experience in leading development projects and technical management.
• Several years of experience with regulatory agencies (e.g. EMA, FDA).

Aufgaben

• Develop Drug Device Combination Products and Medical Devices following regulations.
• Provide technical leadership to interdisciplinary teams.
• Create & maintain design documentation and verification activities.

Kenntnisse

Project management

Technical leadership

Collaboration

Regulatory compliance

Ausbildung

University / Master / Bachelor´s degree in mechanical engineering, plastics engineering, medical engineering or similar

Jobbeschreibung

To ensure a rapid processing of your application, please apply only via the “Apply” 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 / 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 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 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

Pursue 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, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!