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Design Assurance Engineer

Requisition Number: N/A

Region: Europe
Country: Czech Republic
City: Trhove Sviny


This is a full time position based in our offices in The Netherlands, Finland, or  Czech Republic!

The Design Assurance Engineer provides input to our contract development teams in the design of medical devices. They ensure that compliance to customer and regulatory requirements is demonstrated and help to ensure the successful transfer of design to manufacturing. They are responsible for accurate and independent evaluation of Design History File documentation and overall Quality System compliance. This position will report to and operate under the direction and guidance of the Design Assurance Manager, based in Hillegom, The Netherlands.


  • Review and approval of design verification related documentation including any additional activities e.g. testing for those projects where Phillips-Medisize has designer responsibility, process and equipment verification against the respective URSs (e.g. SAT, DQ for jigs, mould tools, assembly equipment etc.).
  • Ensures that all project related documents are created and well managed according to the regulation and internal quality standards.
  • Approves quality documents related to the NPI and DDC Process.
  • Guides the execution of (process) validations and associated tests to be performed in the pre-production phase in close collaboration with other related/relevant disciplines (including review and approval of documentation).
  • Ensures all project and quality documents are complete, current and stored appropriately.
  • Leads and participates in risk management sessions.
  • Approves quality documents related to the design assurance projects.

Project Management:

  • Manages and monitors day-to-day project documentation.
  • Identifies required capabilities and resources in support of the project scope and deliverables.
  • Participates in development in the area of project management, product development, process development and tooling.
  • Participates in (CMO) design review sessions.
  • Develops and improves the effectiveness of projects and processes under his/her responsibility.
  • Reports project status to Design Assurance Manager and Project Manager.

Customer and Supplier Relations:

  • Selects applicable regulation based on the intended use of the product, its classification, and customer requirements, stipulated in agreement with the customer.
  • Manages correct project documentation with customer and suppliers.
  • Communicates project status to customers. 
  • Ensures a smooth transfer of the project documentation from Pre-Production stage into Final Production stage.


Qualifications - Education & Experience

  • Has 3-5 years of relevant experience in a regulated environment.
  • Has a Bachelor’s degree or higher in Engineering, Quality/Regulatory Affairs or a related discipline.
  • Has experience in CMO plastics industry with international customers (preferred).
  • Knowledge of Quality Management Systems (preferred).
  • Relevant knowledge of GMP, ISO 13485, FDA 21CFR820, ISO 14971 or FMEA’s and other applicant standards.


Qualifications - Skills & Competencies

  • Windows, Word, Excel, Access, Power Point, MS Project Experience in production creation/development and product industrialization is a pro.
  • Seen as respected authority/colleague in previous job.
  • English at Business and Technical Proficiency at CEFR C1 level.
  • Has good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, customers,
  • vendors and partners.
  • Is able to travel occasionally to meet with customers / project teams.
  • Is able to work independently and as a member of a cross-functional team to multi-task and do what it takes to meet high expectations and tight deadlines.
  • Will be working on highly visible projects in high-pressure situations.


To be considered for this position:
Please send your CV and application to Heleen Stork - Corporate Recruiter, EU.




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