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SHSHL Medical

Business Process Manager Verification & DFM(m/w/x)

Zug
Full-timeWith Home OfficeSenior

Process design and improvement for product verification and manufacturability of advanced self-injection devices. 5+ years process management experience in medical device or pharma industry required. Flexible hours, hybrid working policy.

Requirements

  • 5+ years of relevant experience in process management within the medical device or pharmaceutical industry
  • Strong knowledge of product development, verification processes, design controls, and DFM principles
  • Excellent strategic thinking, problem-solving, and analytical capabilities
  • Ability to influence and communicate effectively across all organizational levels
  • Ability to work in a fast-paced, global environment with multiple priorities
  • Bachelor’s or Master’s degree in Engineering, Quality Management, Industrial Engineering or related field
  • Fluency in English
  • Familiarity with PLM systems and digital documentation workflows
  • Experience applying agile methodologies in process design
  • Certification in Lean Six Sigma, Process Management or Project Management is a plus
  • Training in DFM methodologies and verification standards preferred
  • Experience with ISO 13485, FDA regulations, or similar compliance frameworks
  • German skills are a plus

Tasks

  • Design and implement end-to-end business processes for Design Verification and DFM
  • Continuously improve processes related to Design, Risk Management, Testing, and Manufacturing Readiness
  • Ensure compliance with regulatory and quality standards throughout the product lifecycle
  • Collaborate with R&D, Quality, Regulatory, Manufacturing Engineering, Operations, and IT to harmonize processes
  • Develop and maintain process documentation, including Work Instructions, Templates, and Guidelines
  • Create training materials to ensure compliance with medical standards and company QMS
  • Conduct workshops and training sessions to identify process gaps and support change management
  • Translate business needs into functional solutions with system architects for PLM implementation
  • Monitor process performance and report KPIs to drive continuous improvement
  • Collect user feedback to enhance process efficiency

Work Experience

  • 5 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent
  • GermanBasic

Tools & Technologies

  • PLM systems
  • Lean Six Sigma
  • DFM methodologies
  • ISO 13485

Benefits

Flexible Working

  • Flexible hours
  • Hybrid working policy

Diverse Work

  • Challenging assignments

Informal Culture

  • Multicultural team
  • Inclusive and collaborative environment

Modern Office

  • Modern working environment
  • State-of-the-art facilities

Other Benefits

  • Personal and professional development
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SHL Medical and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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