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Senior Software Project Manager(m/w/x)
Leading end-to-end software development for medical devices (SaMD/AI) in a clinical setting. Project management experience in regulated medical device development required. Agile methodologies focus.
Requirements
- Degree in Computer Science or related
- Project management experience in regulated industries
- Experience with medical device regulations
- Familiarity with SaMD or AI projects
- Mastery of agile methodologies
- Proficiency with project management tools
- Open-mindedness and drive for software initiatives
- Excellent interpersonal skills
- Exceptional stakeholder management and communication
- Great planning and risk management
- Ability to manage budgets and resources
- Strong analytical and decision-making skills
- Flair for fostering collaboration and transparency
Tasks
- Lead end-to-end software development initiatives
- Ensure delivery on time, scope, and budget
- Manage project timelines, deliverables, and risks
- Report on project dependencies and progress
- Collaborate with cross-functional engineering and marketing teams
- Ensure compliance with medical device standards
- Oversee the full software development lifecycle
- Manage requirements, design, and verification processes
- Coordinate post-market surveillance and validation
- Drive alignment across various business units
- Manage internal and external stakeholders
- Communicate risks and mitigations to executives
- Maintain documentation for regulatory and audit requirements
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- EU MDR
- FDA
- ISO 13485
- IEC 62304
- Scrum
- SAFe
- LeSS
- Jira
- Confluence
- MS Project
Benefits
Learning & Development
- Personal development opportunities
- Continuous professional and personal development
Other Benefits
- Professional employee benefits
Additional Allowances
- Financial employee benefits
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Senior Software Project Manager(m/w/x)
Leading end-to-end software development for medical devices (SaMD/AI) in a clinical setting. Project management experience in regulated medical device development required. Agile methodologies focus.
Requirements
- Degree in Computer Science or related
- Project management experience in regulated industries
- Experience with medical device regulations
- Familiarity with SaMD or AI projects
- Mastery of agile methodologies
- Proficiency with project management tools
- Open-mindedness and drive for software initiatives
- Excellent interpersonal skills
- Exceptional stakeholder management and communication
- Great planning and risk management
- Ability to manage budgets and resources
- Strong analytical and decision-making skills
- Flair for fostering collaboration and transparency
Tasks
- Lead end-to-end software development initiatives
- Ensure delivery on time, scope, and budget
- Manage project timelines, deliverables, and risks
- Report on project dependencies and progress
- Collaborate with cross-functional engineering and marketing teams
- Ensure compliance with medical device standards
- Oversee the full software development lifecycle
- Manage requirements, design, and verification processes
- Coordinate post-market surveillance and validation
- Drive alignment across various business units
- Manage internal and external stakeholders
- Communicate risks and mitigations to executives
- Maintain documentation for regulatory and audit requirements
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- EU MDR
- FDA
- ISO 13485
- IEC 62304
- Scrum
- SAFe
- LeSS
- Jira
- Confluence
- MS Project
Benefits
Learning & Development
- Personal development opportunities
- Continuous professional and personal development
Other Benefits
- Professional employee benefits
Additional Allowances
- Financial employee benefits
About the Company
Ambu A/S
Industry
Healthcare
Description
Ambu ist ein international führendes Medizintechnikunternehmen, das sich auf die Verbesserung der Patientensicherheit und Effizienz im klinischen Alltag konzentriert.
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Software Product Owner - Embedded Software(m/w/x)
Full-timeOn-siteExperiencedAugsburg - Ambu A/S
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