Device Engineer for Medical Devices (temp. for 1,5 years)

Schweiz, Basel-Stadt, Basel Headquarter

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• Job facts

Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.

"Global Technical Development" (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does.

In “Europe Biologics“ (PTDE), we support biologics from Phase I into the Market. Our activities encompass process development for Drug Substance (DS) and Drug Product (DP), market formulation design and process development, device development, clinical manufacturing of DS and parenteral DPs, analytical method development, validation and release of clinical supply, development documentation submissions and transfer of development projects to commercial manufacturing.

As the Device Development Department within PTDE we are 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. Roche is recruiting for a Senior Device Engineer to support the development and maintenance of drug delivery devices (e.g. Prefilled Syringes with Needle Safety Devices, Auto-injectors, high-volume Patch-injectors, oral delivery devices).

The Device Engineering group performs combine design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices that meet the needs of patients, healthcare providers and Health Authorities.

The role will require considerable multi-functional interaction, notably including QA, Regulatory Affairs, Clinical and Commercial functions. As a Device Engineer, you will report to the Section Head of Device Engineering and will be integrated into the Roche Device Development function. Your primary responsibilities will be:

• You will support project teams to successfully bring combination products and medical devices to the market


• You will evaluation new and breakthrough technologies. In addition, you will apply theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to assure devices maintain the required level of performance throughout the life of the product


• You will author design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and DHF creation/maintenance DHF), conformity assessments, and risk management documentation.


• You will apply your knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30)

Would you like to contribute through these tasks? We are looking for you if you are fulfilling the following qualifications.

• University level education (engineering degree or related discipline) preferably in medical device related area


• Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices.


• Knowledge of the following: drug delivery devices, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes and transport studies and validation


• Excellent documentation, presentation and interpersonal communication skills with an excellent command of English language and proficiency in German preferable.

Have we sparked your interest? Apply now.

For questions please call the Recruiting Team Switzerland: +41616822550

• Who we areBei Roche leisten 94,000 Menschen in 100 Ländern Pionierarbeit im Gesundheitswesen. Gemeinsam haben wir uns zu einem weltweit führenden, forschungsorientierten Healthcare-Konzern entwickelt. Unser Erfolg baut auf Innovation, Neugier und Vielfalt.
  
  Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.


• Job facts
  
  
  
  • Location Schweiz, Basel-Stadt, Basel Headquarter
  
  
  • Function Technical Development
  
  
  • Subfunction Medical Device Technology Development
  
  
  • Schedule Vollzeit
  
  
  • Job level Individual contributor
  
  
  • Job type Temporär (Befristet)
  
  
  • Division Roche Pharmaceuticals
  
  
  • Posted since 2018/09/20
  
  
  • Job-ID 201807-113481
  
  


• Get in touchMrs. Leila Beil


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