Cansu Şen

Experience

• 

  Bıçakcılar Tıbbi Cihazlar

  Apr 2018 - Aug 2018

  Part Time R&D Engineer
• 

  Occlutech

  Mar 2019 - now

  •Led end-to-end new product development, defining technical and user requirements in close collaboration with marketing and cross-functional teams.•Successfully managed project scope, timelines, budgets, and resources for EU MDR and FDA submissions, ensuring compliance with quality standards for Class II and III devices.•Proactively identified and resolved challenges across R&D and regulatory processes, ensuring alignment with overall objectives.•Coordinated audits with Notified Bodies and maintained audit-ready documentation to support successful regulatory submissions.•Mentored and led R&D team members, providing guidance on technical development, regulatory compliance, and project management.•Plan, perform, and document DVV testing including ISO 10993 biocompatibility tests and animal testing, while managing DHF for regulatory submissions and ensuring audit readiness.•Oversee validation activities:• Packaging validation: Assessing integrity and sterility under various environmental conditions.• Transport validation: Simulating real-world distribution scenarios to ensure product quality.• Shelf-life activities: Conducting real-time and accelerated aging conditioning per ISO 11607-1. Show less • Preparing project timelines, milestones, and project budget plans.• New product development. • Performing feasibility studies for new projects. Generating budget and project plans and submitting them for review by upper management. • Planning and executing necessary verification and validation testing • Perform staff training and manufacturing line control to transfer all the specifications and methods of the designed products to the manufacturing stage.• Working in coordination with the clinical team for design and clinical development of Occlutech devices• Working with the Regulatory Affairs department and generating and providing the required R&D documents for product certification. • Managing DVV testing including biocompatibility (per ISO 10993) and bench testing • Completed full bench testing, biocompatibility and animal testing suite for US FDA and MDR submissions Show less

  • R&D Engineer II

    Oct 2023 - now

  • R&D Engineer

    Apr 2023 - Oct 2023

  • R&D Engineer

    Nov 2020 - Apr 2023

  • R&D Specialist

    Mar 2019 - Nov 2020