Design Risk Engineer & Development Support

ProClinical Limited
United Kingdom
03 Oct 2017
05 Nov 2017
Contract Type
Full Time
ProClinical is seeking a Design Risk Engineer & Development Support job at a leading global medical device company, to be based in Switzerland on a permanent basis. The duty of the Design Risk Engineer is to support our Quality Department team in Zurich/Kloten we are looking for an experienced and motivated Development Support & Design Risk Engineer. In this role, you'll be supporting the Product Development in different types of projects to ensure that all deliverables are established on time and in the required quality. You'll also be reviewing the Engineering Change Orders to make sure that quality relevant aspects are covered Job Responsibilities: * Ensure a compliant execution of development projects by PD and Operations (in collaboration with the Site Quality Managers) * Ensure that Design Control relevant deliverables are established on time and in the required quality * Act as an advisor to development project members to help them find a pragmatic way of achieving compliance * Ensure the proper handover of the projects from the development teams to the sites from a quality perspective (Design Transfer) * Approve / Review Change Requests and other technical documentation as described in the DC process * Participation in Design Review meetings and review of the Design Review documentations * Review and support the Design Risk Management execution * Support the onboarding of new suppliers in product lifecycle management projects and ensure the design transfer is performed according to the QMS regulation Skills and Requirements: * Engineering or Science University degree * 2 years of experience in the Medical Device industry minimum * Basic knowledge of ISO 13485, 21 CFR 820, ISO 14971 * Experience from interacting with project managers under pressure, from cross-functional work. * Experience in Product Development and leading workshops * Experienced in effective and compliance design transfer of new products and technologies in production environment * At ease in discussion with the TPL (Technical project leader) and withstand the tendency to skip necessary steps or do them insufficiently. To Apply: Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Valaince Penteng on [Phone number removed] or upload your CV on our website - [URL removed] A full job description is available on request. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
This job was originally posted as