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TE
Teleflex Incorporated
18d ago

(Senior) Design V&V Engineer(m/w/x)

Bülach
Part-timeOn-siteExperienced

Description

In this role, you will drive product quality by managing complex design verification and validation strategies while ensuring the company's medical systems meet all regulatory standards.

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Requirements

  • Technical or scientific degree with professional experience
  • Relevant professional experience, ideally in DVV
  • Advantageous product knowledge in medical devices
  • Knowledge of international regulatory requirements
  • Application of design verification/validation testing
  • Experience leading domain related work packages
  • Experience in interface functions
  • Very good German and English skills
  • Team-oriented, accurate, and self-dependent personality

Education

Vocational certification

Tasks

  • Plan and coordinate design verification and validation activities
  • Document development, re-certification, and product maintenance projects
  • Prepare high-level DVV strategies and assessment plans
  • Review technical documentation for development and maintenance scopes
  • Support technical departments during authority queries and audits
  • Advise internal interfaces on verification and validation activities
  • Ensure compliance with internal SOPs and external standards
  • Optimize and maintain company-wide DVV processes and documentation
  • Develop competencies in design control and risk management
  • Participate in interdepartmental expert groups for DVV

Tools & Technologies

MDRFDA/QSRISO 13485ISO 14971IEC 62366cGxPIEC 60601

Languages

GermanBusiness Fluent

EnglishBusiness Fluent

Benefits

Other Benefits

  • Application accommodation and support
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