(Senior) R&D Process Engineer

Added
14 days ago
Type
Full time
Salary
Salary not provided

Related skills

process optimization iso 13485 fda 21 cfr part 820 regulatory compliance

πŸ“‹ Description

  • Design, implement, and optimize development processes within R&D in accordance with relevant
  • Analyze effectiveness and efficiency of existing processes and manage process improvement and
  • Work cross-functionally with R&D, Quality Management, Quality Assurance and other interfacing
  • Ensure audit readiness and support internal and external audits related to R&D processes.
  • Align development processes within the Brainlab agile methodology.
  • Provide process training and coaching to R&D colleagues and facilitate knowledge sharing across

🎯 Requirements

  • University degree in engineering or life sciences preferred, but other degrees may be considered.
  • Professional experience in the design and development of medical devices or in leading process
  • Knowledge of medical device related standards and regulations such as FDA 21 CFR Part 820 and ISO
  • Flexibility to adjust processes to align with an evolving working model.
  • Solution orientation and a structured nature.
  • Strong communication and documentation skills and ability to work cross-functionally.

🎁 Benefits

  • A mutually-supportive, international team.
  • Meaningful work with a lasting impact on medical technology.
  • 30 vacation days, plus December 24th and December 31st.
  • Flexible working hours as well as hybrid work model within Germany.
  • Bike leasing via cooperation partner "BikeLeasing".
  • Parking garage and safe underground bike storage.
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