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Senior Software Project Manager(m/w/x)
End-to-end project management for single-use endoscopy and patient monitoring solutions. Medical device regulations (EU MDR, FDA) and agile-at-scale experience required. Personal development opportunities, exciting job challenges.
Anforderungen
- Bachelor's or Master's degree in Computer Science, Engineering, Life Sciences, or related field
- Proven project management experience in software development in medical device or healthcare technology industry, or other regulated industry
- Proven track record with medical device regulations (EU MDR, FDA), quality systems (ISO 13485), and software lifecycle standards (IEC 62304)
- Familiarity with Software as a Medical Device (SaMD) and/or AI-based software projects from concept to commercialization
- Mastery of agile methodologies (Scrum, SAFe, LeSS, or similar) and experience in agile-at-scale environment
- Proficiency with project management tools (Jira, Confluence, MS Project, or similar)
- Open-mindedness and eagerness to drive new software initiatives
- Excellent interpersonal skills
- Exceptional stakeholder management and communication skills (technical and non-technical audiences)
- Great planning, scheduling, and risk management capabilities
- Ability to manage budgets, resources, and priorities across complex projects
- Strong analytical thinking, problem-solving, and decision-making skills
- Fostering collaboration, accountability, and transparency across diverse teams
Aufgaben
- Lead end-to-end project management
- Ensure timely, scoped, and budgeted delivery
- Plan and manage project timelines
- Report on deliverables, dependencies, and risks
- Collaborate with marketing, engineering, quality, regulatory, clinical, and product development teams
- Ensure compliance with medical device standards
- Oversee software development lifecycle
- Define requirements
- Design software solutions
- Verify and validate software
- Manage post-market surveillance
- Drive alignment across business units
- Manage internal and external stakeholders
- Communicate progress, risks, and mitigations
- Ensure documentation meets regulatory requirements
- Maintain traceability for audits
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Jira
- Confluence
- MS Project
- EU MDR
- FDA
- ISO 13485
- IEC 62304
- SaMD
- Scrum
- SAFe
- LeSS
Benefits
Weiterbildungsangebote
- Personal development opportunities
- Continuous professional and personal development
Abwechslungsreiche Aufgaben
- Exciting job challenges
Gefällt dir diese Stelle?
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Senior Software Project Manager(m/w/x)
End-to-end project management for single-use endoscopy and patient monitoring solutions. Medical device regulations (EU MDR, FDA) and agile-at-scale experience required. Personal development opportunities, exciting job challenges.
Anforderungen
- Bachelor's or Master's degree in Computer Science, Engineering, Life Sciences, or related field
- Proven project management experience in software development in medical device or healthcare technology industry, or other regulated industry
- Proven track record with medical device regulations (EU MDR, FDA), quality systems (ISO 13485), and software lifecycle standards (IEC 62304)
- Familiarity with Software as a Medical Device (SaMD) and/or AI-based software projects from concept to commercialization
- Mastery of agile methodologies (Scrum, SAFe, LeSS, or similar) and experience in agile-at-scale environment
- Proficiency with project management tools (Jira, Confluence, MS Project, or similar)
- Open-mindedness and eagerness to drive new software initiatives
- Excellent interpersonal skills
- Exceptional stakeholder management and communication skills (technical and non-technical audiences)
- Great planning, scheduling, and risk management capabilities
- Ability to manage budgets, resources, and priorities across complex projects
- Strong analytical thinking, problem-solving, and decision-making skills
- Fostering collaboration, accountability, and transparency across diverse teams
Aufgaben
- Lead end-to-end project management
- Ensure timely, scoped, and budgeted delivery
- Plan and manage project timelines
- Report on deliverables, dependencies, and risks
- Collaborate with marketing, engineering, quality, regulatory, clinical, and product development teams
- Ensure compliance with medical device standards
- Oversee software development lifecycle
- Define requirements
- Design software solutions
- Verify and validate software
- Manage post-market surveillance
- Drive alignment across business units
- Manage internal and external stakeholders
- Communicate progress, risks, and mitigations
- Ensure documentation meets regulatory requirements
- Maintain traceability for audits
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Jira
- Confluence
- MS Project
- EU MDR
- FDA
- ISO 13485
- IEC 62304
- SaMD
- Scrum
- SAFe
- LeSS
Benefits
Weiterbildungsangebote
- Personal development opportunities
- Continuous professional and personal development
Abwechslungsreiche Aufgaben
- Exciting job challenges
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Ambu A/S
Branche
Healthcare
Beschreibung
Ambu ist ein international führendes Medizintechnikunternehmen, das sich auf die Verbesserung der Patientensicherheit und Effizienz im klinischen Alltag konzentriert.
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Vollzeitnur vor OrtSeniorAugsburg - Fresenius Kabi Deutschland GmbH
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