Medical Device Design Control Specialist for Combination Products

vor 1 Woche


Basel, Basel-Stadt, Schweiz Randstad - Medium prio Vollzeit

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

The ideal 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.

Responsibilities:

  • 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.

Key Deliverables:

  • Product requirement specifications
  • User requirements documentation
  • Verification plans, protocols, and reports
  • Contribution to elements of the Technical File and Design History File (DHF)

This is a unique opportunity to play a key role in an expanding team and contribute to impactful projects within the drug-device combination product space.



  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleR oche is recruiting for an experienced Device Engineer to support the development of drug delivery devices, including Prefilled Syringes with Needle Safety Devices, Autoinjectors, and high-volume Patch-injectors.About the TeamThe Device Engineering group is responsible for the design, engineering, testing, and manufacturing of reliable and safe drug...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleRoche is seeking a highly skilled Device Engineer to join the Device Development Department within Roche Technical Development. The successful candidate will be responsible for the development and support of drug delivery devices for the product portfolio.The Device Engineering group performs combine design, engineering, testing, and manufacturing to...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleWe are seeking a highly skilled Device Engineer to join our team at Roche Technical Development, specifically within the Device Development Department.This department is responsible for the development and support of drug delivery devices for our product portfolio, covering a range of engineering disciplines from requirements definition to...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleRoche is seeking a highly skilled Device Engineer to join our Device Development Department. As a key member of our team, you will be responsible for the development and support of drug delivery devices, including Prefilled Syringes with Needle Safety Devices, Autoinjectors, and high-volume Patch-injectors.Key ResponsibilitiesLead projects to...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Job DescriptionWe are seeking a skilled Device Engineer to join our team at Roche Technical Development in the Device Development Department.About the PositionThe successful candidate will be responsible for the development and support of drug delivery devices, including Prefilled Syringes with Needle Safety Devices, Autoinjectors, and high-volume...


  • Basel, Basel-Stadt, Schweiz ResMed Vollzeit

    Job DescriptionWe are seeking a skilled Technical Services Specialist to join our team in Basel, Switzerland.Key Responsibilities:Repair and maintenance of medical devicesTechnical incoming goods inspection of medical devicesFault analysis and assessment of defective devices and assembliesPreparation of repair reports, test and measurement...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Join the Device Development DepartmentRoche is looking for a skilled Senior Mechanical Engineer to support the development and maintenance of drug delivery devices, including Prefilled Syringes with Needle Safety Devices, Autoinjectors, and high-volume Patch-injectors.The ideal candidate will have a strong background in mechanical engineering and experience...


  • Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    Job Summary:We are seeking an experienced IT Professional to join our team as a Medical Technology Specialist. The successful candidate will be responsible for integrating medical devices into our network, ensuring seamless data exchange between devices and hospital systems, and providing expert support for server and client-based middleware and expert...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Company OverviewRoche, a leading pharmaceutical company, is at the forefront of digital health innovation. Our mission is to harness the power of technology to transform healthcare.Job DescriptionWe are seeking an experienced Senior Device Operations Specialist to join our Digital Biomarker team. As a key member of this team, you will be responsible for...


  • Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    Job Title: Medical Technology SpecialistJob Summary: We are seeking an experienced IT Specialist to join our team in Basel, Switzerland. The ideal candidate will have a strong background in medical technology and network integration.Main Responsibilities:Network integration of all medical devicesEnsuring data exchange between medical devices and hospital...


  • Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    Job Summary:We are seeking an experienced IT Specialist to join our team in Basel, Switzerland. The ideal candidate will have a strong background in medical technology and network integration, with excellent communication skills in German and English.Main Responsibilities:Network integration of all medical devicesEnsuring data exchange between medical...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The Device Development Department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support.


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleAt Roche, we are dedicated to creating innovative digital endpoints and outcomes that redefine the way we measure disease progression in clinical drug trials. We are seeking a Device Operations Manager to drive the deployment and operations of digital biomarker devices, enabling the collection of digital endpoints for multiple disease areas.Key...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleWe are seeking a seasoned Digital Biomarker Device Operations Manager to join our team at Roche. As a key member of our Digital Biomarker operations subchapter, you will be responsible for establishing and driving the digital biomarker device operations capability, ensuring the deployment of digital biomarker products in clinical trials, and...


  • Basel, Basel-Stadt, Schweiz emerson Vollzeit

    About the Job:This role is for a highly skilled Control Systems Specialist to join our team at Emerson. As a Control Systems Specialist, you will be responsible for developing functional and design specifications for Emerson Control systems under supervision of the Lead Engineer and in co-operation with customers.Responsibilities:Develop functional and...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleAt Roche, we're committed to harnessing the potential of digital health technology to revolutionize the way we develop personalized medicines for patients. As a Device Operations Manager in our Digital Biomarker team, you'll play a critical role in driving the deployment of digital biomarker devices in clinical trials, enabling the collection of...

  • Purchasing Specialist

    vor 4 Wochen


    Basel, Basel-Stadt, Schweiz Danaher Corporation Vollzeit

    About the RoleWe are seeking a highly skilled Purchasing Specialist to join our team at Radiometer, a leading company in the medical device industry. As a key member of our Supply Chain Team, you will be responsible for managing the supply chain for our production entities, ensuring timely delivery of products, raw materials, and services.Key...


  • Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    Job Summary: We are seeking an experienced IT Specialist to join our team in Basel, Switzerland. The ideal candidate will have a background in medical technology and experience with network integration, data exchange, and system administration.Main Responsibilities:•Configure and integrate medical devices into our network•Ensure seamless data exchange...


  • Basel, Basel-Stadt, Schweiz Straumann Group Vollzeit

    Job Title:Global Head of Product Marketing Digital SolutionsAbout Straumann Group:Straumann Group is a leading company in the dental implant industry.Job Description:The Global Head of Product Marketing will lead the market expansion and commercial success of Straumann digital solutions, including digital devices, clinical software, patient-specific design...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleAt Roche, we are dedicated to creating innovative digital endpoints and outcomes that redefine the way we measure disease progression in clinical drug trials. We are seeking a Device Operations Lead to drive the deployment of digital biomarker devices and accelerate the development of novel digital biomarker data insights products.Key...