Ambu A/S
Senior Software Project Manager(m/w/x)
Vollzeit
Keine Angabe
Augsburg
AM
Ambu24 Tage
Software Process Owner(m/w/x)
Vollzeit
Senior
AI/ML Job
Keine Angabe
Augsburg
Nejo KI-Zusammenfassung
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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Anforderungen
- •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
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
8 Jahre
Deine Aufgaben
- •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
Sprachen
Englisch – verhandlungssicher
Deine Vorteile
Weiterbildungsangebote
- •Personal development opportunities
Sonstige Vorteile
- •Wide range of employee benefits
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Ambu erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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