Design Assurance Engineer (f/m)

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Design Assurance Engineer / Design Transfer (f/m)

Business Unit: Global Quality Management
Location: Zurich
Duration: 3-4 months with possible extension

The position is supporting Product Development in different types of projects to ensure that all deliverables are established on time and in the required quality. The person is ensuring that the Design Risk Management process is followed and support the management of standards and guidances.

Overall 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.
  • Support the handover of the projects from the development teams to the sites from a quality perspective (Design Transfer) and support the sites in the compliant introduction of the new processes
  • Participation in Design Review meetings and review of the Design Review documentations.
  • Drive and support the Process Risk Management, Equipment Qualification and Process Validation execution based on the Design Risk Assessments.
  • Support the on-boarding of new suppliers for the relevant projects.
  • Ensure the Design Transfer is performed according to the QMS regulation.
  • Pragmatic but compliant application of the PLCM process.
  • Ensuring the Design Control process is followed.
  • Competence in development as a key asset for creating acceptance and momentum in Development
  • Ability to make self-reliant decisions considering the compliance risks.

Your Profile
  • Higher education (preferably engineering or science)
  • 6 years of experience in the Medical Device industry (preferably Development or Quality Management) and basic knowledge of ISO 13485, 21 CFR 820, ISO 14971.
  • Consequent and efficient, compliant and pragmatic. The position will always be on the line to decide what is acceptable from a Quality Management perspective and what not. The position holder must be strong in discussion with the TPL (Technical project leader) and withstand the tendency to skip necessary steps or do them insufficiently.
  • She must therefore be capable of working cross-functionally.
  • Experience from interacting with project managers under pressure, from cross-functional work and a basic understanding from all functions in the company. Experience in Product Development and leading workshops.
  • Experienced in effective and compliance design transfer of new products and technologies in production environment

Please contact me as soon as possible if you are interested in this opportunity!

Best regards

Elena Bollinger

T: +41 (0)
E: e.bollinger(at)

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.