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Principal Design Engineer

Sanofi-Aventis

Frankfurt am Main, Germany

Your responsibilities

  • Contribute to and ensure execution of Platform Technology Roadmap (Design & Manufacturing technology) for our Sanofi Pen Injector Portfolio;
    • Owner and Subject Matter Expert of technology platform development and life cycle:
    • Acts as Lead Design Engineer in Key Development Project Core Teams;
    • Responsible for final mechanical design concept selection including connectivity;
    • Ensures platform design robustness based on agreed Design For Manufacturing & Assembly criterias;
    • Sets device functional specifications for relevant development and verification testing;
    • Defines standard platform documentation to comply with design control requirements;
  • Ensures design-to-value and target cost of goods realization;
  • Leads technical expert and design reviews of platform projects;
  • Ensures adequate Intellectual Property (IP) protection of platform technology and related subsystems;
  • Continuous technical assessment of Core Platform technologies over Life Cycle Managment incl. benchmark and challenge studies;
  • Ensures system integration of platform technology with primary container subsystem and drives improvements of pen interaction with container;
  • Drives efficient and compliant design transfer process to manufacturing sites;
  • Liaise with internal and external Design Engineers, strategic external partners, Primary Container Development, manufacturing sites and IP Department
  • SME for platform related regulatory aspects including submission preparation, agency meetings and reviews, post approval inspection (PAIs) and general quality system inspections;
  • Supports reporting as required to authority in case of severe quality and/or product safety events related to platform technology;
  • Represents Sanofi in pen injector related national and international standardization groups.

Your qualifications

  • Masters degree in mechanical and plastic engineering, mechanical and/or mechatronic system design or medical technology;
  • Profound design experience in a leading role of technical system or subsystem design, preferably for Drug Device Combination products;
  • Proven track record of successful design transfers into commercial production;
  • Knowledge of standard design tools, e.g. CAD, FEA, dynamic simulation, Moldflow, Tolerance Analysis tools, Design-FMEA and others;
  • Project management and decision making skills in complex technical environment;
  • Provides leadership to international, cross-functional expert teams;
  • Experienced with relevant regulatory requirements, e.g. 21 CFR 820;
  • Open and transparent communication style also during audits;
  • Proactive and efficient working style;
  • Systematic and fact based problem solving attitude;
  • Fluent in English, advanced in German.

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