Join a global leader in the pharmaceutical industry as a Design Control Engineer within the Combination Products Development team, and play a pivotal role in design control, risk management, technical documentation, and cross-functional collaboration with R&D, Quality, Technical Operations, and Manufacturing teams. This role focuses on the development, optimization, and lifecycle management of cutting-edge drug-device combination products for respiratory, subcutaneous, and intravenous drug delivery .
Key Responsibilities
- Develop and maintain Design Control documentation throughout the product lifecycle.
- Author and manage Risk Management documentation in compliance with ISO 14971 .
- Support the development, customization, qualification, and optimization of drug delivery systems and combination products.
- Contribute to Design Verification and Validation activities.
- Participate in Design Reviews and technical assessments.
- Assist in technology transfer and industrialization activities.
- Prepare technical documentation for quality and regulatory submissions.
- Collaborate with R&D, Quality, Regulatory Affairs, Technical Operations, and external partners .
- Ensure compliance with regulatory requirements and industry standards .
- Stay updated on industry trends, regulations, and best practices in Combination Products and Drug Delivery Systems.
Required Qualifications
- Master’s degree or PhD in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related scientific discipline .
- Minimum 5 years in Combination Products, Drug Delivery Systems, Medical Device Development, or Pharmaceutical/Biotechnology environments .
- Strong background in Design Control, Risk Management, Product Development, Technical Documentation, and Verification & Validation .
- Experience working in regulated environments .
Hands-on experience with the following are highly appreciated:
- Autoinjectors, Pen Injectors, Prefilled Syringes, Safety Syringes, Inhalation Devices, or Drug Delivery Platforms .
- Human Factors Engineering or Usability Engineering .
- ISO 14971, ISO 13485, FDA Design Controls, MDR, or Combination Product regulations .
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Design Control Engineer – Combination Products & Drug Delivery Systems in Bern Arbeitgeber: Alten
ALTEN ist ein hervorragender Arbeitgeber, der dir als Werkstudent im Projektmanagement am Standort Berlin die Möglichkeit bietet, praktische Erfahrungen in einem dynamischen Umfeld zu sammeln. Unsere offene und inklusive Unternehmenskultur fördert die persönliche und berufliche Entwicklung, während du an innovativen Projekten in der Luftfahrtbranche mitarbeitest. Zudem profitierst du von flexiblen Arbeitszeiten und der Chance, mit internationalen Teams zusammenzuarbeiten, was deine Karrierechancen erheblich steigert.
