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Product Design Specialist

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Randstad (Schweiz) AG Vollzeit
Job Description

We are seeking a highly skilled Design Control Specialist to support ongoing and new projects involving drug-device combination products.

The successful candidate will bring extensive experience in design control for medical devices and combination products, working independently to create and manage key documentation throughout the product lifecycle.

  • Document Creation: Write comprehensive design control documents, including Product Requirement Specifications, verification plans, protocols, and reports.
  • Requirements Gathering: Collaborate with various internal functions to define user requirements and translate them into design inputs, all consolidated into a single document.
  • Planning & Execution: Develop and implement verification plans, set up testing protocols, and work closely with suppliers and Contract Manufacturing Organizations (CMOs) to ensure capabilities meet project requirements.
  • Project Involvement: Manage design control activities across multiple projects (2 to 3), specifically focusing on drug-device combination products.
  • Compliance & Reporting: Ensure all documentation complies with internal quality standards and is ready for QA approval. Provide regular status updates and reports to the project lead.