Design Engineer for Combination Products and Autoinjector Platforms
In this role, you will be part of a multidisciplinary team responsible for the development of medical devices and drug-device combination products. Your main focus will be on designing and delivering robust device platforms and ensuring compliance with regulatory requirements.
Key Responsibilities:
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o Development of medical devices and drug-device combination products following regulatory requirements (FDA, EU MDR) and standards (ISO, IEC)
o Act as a systems engineer for both new drug-device combination product development and enhancement of existing platforms
o Maintain the design of medical devices and drug-device combination products in life-cycle management
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o Provide technical leadership to interdisciplinary teams (design, quality, process engineers, etc.)
o Coordinate technical tasks with project/product core teams
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o Create and maintain Autoinjector platform & device design documentation (CAD data, dFMEA, technical specifications, etc.)
o Plan and maintain design verification activities and documentation (incl. evaluation and interpretation of test results)
Requirements:
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o University/Master/Bachelor's degree in engineering (mechanical engineering, plastics engineering, medical engineering or similar)
o Extensive experience in medical device or combination product development, industrialization or manufacturing
o Experience in leading development projects and technical management of interdisciplinary development teams
o 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)
o Qualified in project management activities (e.g. PMP)
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o Excellent communication and teamwork skills
o Confident attitude, committed and used to working independently
What We Offer:
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o Bring your expertise to the development of innovative medical devices and combination products
o Contribute to a dynamic and multidisciplinary team
o Enjoy opportunities for professional growth and development
About Us:
We are a leading player in the pharmaceutical industry, dedicated to improving patients' lives through innovative healthcare solutions.
Join us and discover a workplace that values diversity, equality, and inclusion.