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Ambu
last mo.

Software Process Owner(m/w/x)

Augsburg
Full-timeOn-siteSenior
AI/ML

Description

As a Software Process Owner, you will enhance Medical Device Software development processes, ensuring compliance and efficiency. Your role involves collaborating with teams, monitoring metrics, and providing training to support innovative solutions for patients worldwide.

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Requirements

  • •Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or related field
  • •8+ years of experience in software development in the medical device or healthcare technology industry
  • •5+ years of experience writing standard operating procedures for Medical Device Software
  • •Proven experience with medical device regulations (EU MDR, FDA), quality systems (ISO 13485), and software lifecycle standards (IEC 62304)
  • •Experience with Software as Medical Device (IEC 82304) and AI functionality is an advantage
  • •Proven experience with process ownership and software process governance
  • •Mastering agile methodologies (Scrum, SAFe, LeSS, or similar) in a Medical Device context
  • •Mindset for quality, efficiency and optimization
  • •Open-mindedness and eagerness to drive process creation and implementation
  • •Excellent written and verbal communication skills in English
  • •Excellent interpersonal skills
  • •Exceptional stakeholder management and communication skills
  • •Great planning, scheduling, and prioritization capabilities
  • •Strong analytical thinking, problem-solving, and decision-making skills
  • •Flair for fostering collaboration, accountability, and transparency across diverse teams

Education

Bachelor's degree
OR
Master's degree

Work Experience

8 years

Tasks

  • •Ensure compliance with medical device regulations and standards
  • •Define and monitor Medical Device Software Process metrics and KPIs
  • •Identify gaps and drive corrective and preventive actions
  • •Support process adoption through training and coaching
  • •Provide templates and documentation guidance
  • •Collaborate with R&D, Quality Assurance, and Regulatory Affairs teams
  • •Ensure accuracy and completeness of documentation
  • •Maintain effective and current Software procedures and Quality Handbooks
  • •Design Control documentation for ongoing and released projects
  • •Participate in internal and external audits as a subject matter expert

Languages

English – Business Fluent

Benefits

Learning & Development

  • •Personal development opportunities

Other Benefits

  • •Wide range of employee benefits
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