Senior Software Project Manager

Ambu; Augsburg; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Benefits dieser Stelle

Personal development opportunities

International head office environment

Zusammenfassung

Ambu seeks an experienced Software Project Manager to lead cross‑functional software initiatives from concept through regulatory approval and market launch. You will coordinate marketing, engineering, quality, regulatory, clinical and product teams to ensure compliance with ISO 13485, IEC 62304, MDR, and FDA requirements.

You will oversee the full software lifecycle, drive risk management, maintain traceability, manage stakeholders, and report progress to executives.

Qualifikationen

• Hold a Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or related field.
• Have proven project management experience in software development in the medical device or healthcare technology industry, or other regulated industry.
• Have proven track record working with medical device regulations (EU MDR, FDA), quality systems (ISO 13485), and software lifecycle standards (IEC 62304).
• Are familiar with Software as a Medical Device (SaMD) and/or AI‑based software projects from concept to commercialization.
• Are mastering agile methodologies (Scrum, SAFe, LeSS, or similar) and experience with working in an agile‑at‑scale environment.
• Have proficiency with project management tools (e.g., Jira, Confluence, MS Project, or similar).
• Are open-minded and eager to drive new software initiatives in a company with a strong legacy in physical products.

Aufgaben

• Lead end‑to‑end project management of software development initiatives, ensuring delivery on time, within scope, and within budget.
• Plan, manage, and report on project timelines, deliverables, dependencies, and risks.
• Collaborate closely with marketing, engineering, quality, regulatory, clinical, and product development teams to ensure compliance with relevant medical device standards (e.g., ISO 13485, IEC 62304, MDR, FDA 21 CFR Part 820).
• Oversee software development lifecycle, including requirements definition, design, verification/validation, and post‑market surveillance.
• Drive alignment across business units and manage both internal and external stakeholders.
• Communicate progress, risks, and mitigations clearly to executive stakeholders and cross‑functional teams.
• Ensure documentation and traceability meet regulatory and audit requirements.

Kenntnisse

Degree in CS/Engineering

Project management experience

Regulatory knowledge

SaMD/AI software

Agile methodologies

PM tools (Jira/Confluence/MS Project)

Cross-functional collaboration

Ausbildung

Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or related field

Tools

Jira

Confluence

MS Project

Jobbeschreibung

Are you an experienced Software Project Manager with a background in the Medical Device industry? Do you thrive in a dynamic international environment, leading a cross‑functional team to develop innovative digital solutions that significantly impact patients’ lives? Then this might be your defining moment. In this exciting position, we are seeking an experienced Software Project Manager to lead complex, cross‑functional software projects from concept through regulatory approval and market launch. join us for a career where you make the difference!

Key Responsibilities

• Lead end‑to‑end project management of software development initiatives, ensuring delivery on time, within scope, and within budget.
• Plan, manage, and report on project timelines, deliverables, dependencies, and risks.
• Collaborate closely with marketing, engineering, quality, regulatory, clinical, and product development teams to ensure compliance with relevant medical device standards (e.g., ISO 13485, IEC 62304, MDR, FDA 21 CFR Part 820).
• Oversee software development lifecycle, including requirements definition, design, verification/validation, and post‑market surveillance.
• Drive alignment across business units and manage both internal and external stakeholders.
• Communicate progress, risks, and mitigations clearly to executive stakeholders and cross‑functional teams.
• Ensure documentation and traceability meet regulatory and audit requirements.

Suggested candidate profile

Skills and experiences can be earned in many ways, and we understand that the best fit for the role cannot be prescribed on paper. You are, however, likely to succeed in this position if you:

Skills

• Hold a Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or related field.
• Have proven project management experience in software development in the medical device or healthcare technology industry, or other regulated industry.
• Have proven track record working with medical device regulations (EU MDR, FDA), quality systems (ISO 13485), and software lifecycle standards (IEC 62304).
• Are familiar with Software as a Medical Device (SaMD) and/or AI‑based software projects from concept to commercialization.
• Are mastering agile methodologies (Scrum, SAFe, LeSS, or similar) and experience with working in an agile‑at‑scale environment.
• Have proficiency with project management tools (e.g., Jira, Confluence, MS Project, or similar).
• Are open-minded and eager to drive new software initiatives in a company with a strong legacy in physical products.

You Have Excellent Interpersonal Skills, Such As

• Exceptional stakeholder management and communication skills (both 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.
• Flair for fostering collaboration, accountability, and transparency across diverse teams.

Join the team!

Reporting to the Senior Manager of Project Management, Endointelligence Solutions, you will join our Respiratory & ENT and EndoIntelligence solutions team in Global R&D based across our Innovation sites in Ballerup, Denmark, Augsburg, Germany and Penang, Malaysia.

Ambu - a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

• We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.