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RORoche Diagnostics Int. AG

System Integration & Testing Project Lead(m/w/x)

Risch-Rotkreuz
Full-timeOn-siteSenior

Integrating HW/SW product functions for clinical and immunochemistry diagnostic systems. 5+ years MedTech development experience required. Cross-functional team leadership and technical coaching.

Requirements

  • Engineering experience with automation passion
  • Technical depth and leadership skills
  • Navigating complex, regulated MedTech environments
  • University degree in Engineering or Natural Sciences
  • 5+ years of experience in medical device development
  • Proven track record in hardware-centric integration
  • Define complex engineering work packages
  • Manage formal design verification (V&V)
  • Maintain compliance in regulated environments
  • Deep knowledge of Agile frameworks (SAFe/Scrum/Kanban)
  • Agile applied to physical product development constraints
  • Exceptional communication skills in English
  • German and Asian culture communication advantageous
  • Ability to influence and negotiate effectively
  • Self-organized and responsible team player
  • Open-minded and enthusiastic about continuous process optimization
  • Capable of dealing with complex, high-pressure situations

Tasks

  • Drive verification and validation strategy
  • Plan and coordinate test campaigns
  • Document requirements and acceptance tests
  • Foster matrix leadership and technical coaching
  • Define cross-functional HW/SW product functions
  • Maintain verification process compliance
  • Implement V&V standards and deliverables
  • Manage and prioritize team/product backlog
  • Use Agile methodologies (SAFe/Scrum)
  • Define testing acceptance criteria
  • Review requirements for testability
  • Perform system design verification
  • Assess system-level product risks
  • Monitor progress across test campaigns
  • Manage deviations and traceability
  • Plan and commission test equipment
  • Monitor budget for design verification
  • Collaborate with technical and non-technical stakeholders
  • Ensure seamless system integration with external partners

Work Experience

  • 5 years

Education

  • Bachelor's degree

Languages

  • EnglishNative
  • Germanis a plus
  • Chineseis a plus
  • Japaneseis a plus
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